<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03020303</url>
  </required_header>
  <id_info>
    <org_study_id>ACHIEVE</org_study_id>
    <nct_id>NCT03020303</nct_id>
  </id_info>
  <brief_title>Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease</brief_title>
  <acronym>ACHIEVE</acronym>
  <official_title>Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals receiving dialysis are at risk of heart failure and heart related death. There is&#xD;
      an urgent need for treatments that reduce the risk of these problems in patients that require&#xD;
      dialysis.&#xD;
&#xD;
      Spironolactone is a pill used to prevent heart failure and related deaths in patients that do&#xD;
      not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes&#xD;
      high blood pressure and can damage the heart. Although spironolactone is very effective in&#xD;
      patients that do not require dialysis, we do not know if spironolactone is effective in&#xD;
      dialysis patients. Our research will help determine if spironolactone reduces heart failure&#xD;
      and heart related deaths in dialysis patients.&#xD;
&#xD;
      The purpose of this study is to determine if spironolactone reduces death or hospitalization&#xD;
      for heart failure and is well tolerated in patients that require dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Globally, over 2 million people receive dialysis for end-stage renal disease (ESRD) and&#xD;
      650,000 new patients start dialysis each year. Furthermore, the number of patients receiving&#xD;
      dialysis is increasing as access to dialysis in the developing world improves and the&#xD;
      prevalence of diabetes and vascular disease rises. Despite technical advances in dialysis,&#xD;
      the outcomes for patients with ESRD are poor. Patients have frequent hospitalizations, poor&#xD;
      health related quality of life and strikingly, high mortality rates.&#xD;
&#xD;
      The most common cause of death in patients receiving dialysis is cardiovascular disease,&#xD;
      accounting for &gt;40% of all deaths. Observational studies suggest a causal pathway to&#xD;
      cardiovascular death that includes progressive ventricular hypertrophy and dilatation as well&#xD;
      as accelerated atherosclerosis. These changes result in myocardial ischemia and cardiac&#xD;
      fibrosis that, in turn, lead to heart failure, arrhythmias and cardiac arrest. Strongly&#xD;
      implicated in this pathophysiology is aldosterone. Mineralocorticoid receptor antagonists&#xD;
      (MRAs) in non-ESRD patients, prevent cardiovascular deaths and small randomized controlled&#xD;
      trials of MRAs in ESRD suggests they may reduce death and may be safe.&#xD;
&#xD;
      Spironolactone is the most commonly used MRA worldwide. We will conduct a multicentre&#xD;
      randomized controlled trial (RCT) to determine if spironolactone reduces cardiac mortality&#xD;
      and hospitalizations for heart failure in patients treated with dialysis. This trial is&#xD;
      called the Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease&#xD;
      (ACHIEVE).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CV Death or Hospitalization for Heart Failure</measure>
    <time_frame>up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cause specific death</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for Heart Failure</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Hospitalization</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for hyperkalemia</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2750</enrollment>
  <condition>Endstage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spironolactone 25 MG Tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 mg of active spironolactone in tablet form</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spironolactone 25Mg Tablet</intervention_name>
    <description>Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.</description>
    <arm_group_label>Spironolactone 25 MG Tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.</description>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&#xD;
&#xD;
               1. ≥45 years or&#xD;
&#xD;
               2. ≥18 with a history of diabetes&#xD;
&#xD;
          2. On dialysis ≥ 90 days&#xD;
&#xD;
          3. On either&#xD;
&#xD;
               1. Hemodialysis prescribed at least 2 treatments per week or&#xD;
&#xD;
               2. Peritoneal dialysis prescribed with at least 1 exchange daily&#xD;
&#xD;
          4. Provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hyperkalemia&#xD;
&#xD;
               1. Serum potassium &gt;5.8 mmol/L in the 6 weeks prior to enrollment or&#xD;
&#xD;
               2. Serum potassium &gt;6.0 mmol/L during active run-in&#xD;
&#xD;
          2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e.&#xD;
             spironolactone or eplerenone).&#xD;
&#xD;
          3. Known sensitivity or allergy to spironolactone&#xD;
&#xD;
          4. Current or planned pregnancy or breastfeeding&#xD;
&#xD;
          5. Scheduled living related donor renal transplant&#xD;
&#xD;
          6. Life expectancy &lt; 6 months in the opinion of a treating nephrologist.&#xD;
&#xD;
          7. Enrolled in another interventional trial testing a mineralocorticoid receptor&#xD;
             antagonist or drug that has a known or likely interaction with spironolactone.&#xD;
&#xD;
          8. Treating physician believes either spironolactone is either absolutely indicated or&#xD;
             absolutely contra-indicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Walsh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>PJ Devereaux, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Tyrwhitt, B.A.</last_name>
    <phone>9055274322</phone>
    <phone_ext>40555</phone_ext>
    <email>jessica.tyrwhitt@phri.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Colin Hardy, B.A.</last_name>
    <phone>9055274322</phone>
    <phone_ext>40694</phone_ext>
    <email>colin.hardy@phri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Canberra Hospital</name>
      <address>
        <city>Garran</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Girish S Talaulikar, MD</last_name>
      <phone>0262442955</phone>
      <email>girish.talaulikar@act.gov.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mona Razavian, MD</last_name>
      <phone>0402069898</phone>
      <email>monarazavian@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northern Beaches Hospital</name>
      <address>
        <city>Frenchs Forest</city>
        <state>New South Wales</state>
        <zip>2086</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Paul Killen, MD</last_name>
      <email>john.killen@healthscope.com.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>Wahroonga</city>
        <state>New South Wales</state>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yvonne Shen, MD</last_name>
      <email>yvonne.Shen@health.nsw.gov.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sydney Adventist Hospital</name>
      <address>
        <city>Wahroonga</city>
        <state>New South Wales</state>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muh Geot Wong, MD, PhD</last_name>
      <phone>0400854109</phone>
      <email>muhgeot.wong@sydney.edu.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Birtinya</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas A Gray, MD</last_name>
      <phone>0752022882</phone>
      <email>nicholas.gray@health.qld.gov.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Wolley</last_name>
      <phone>610450954163</phone>
      <email>martin.wolley@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevan Polkinghorne, MD</last_name>
      <email>kevan.polkinghorne@monash.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Western Health - Sunshine Hospital</name>
      <address>
        <city>Saint Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eugenia Pedagogos, MD</last_name>
      <email>eugenia.pedagogos@wh.org.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica Senhor do Bonfim</name>
      <address>
        <city>Feira De Santana</city>
        <state>Bahia</state>
        <zip>44001-584</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinica Senhor do Bonfim</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40415-065</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Belo Horizonte</name>
      <address>
        <city>Santa Efigênia</city>
        <state>Belo Horizonte</state>
        <zip>30150221</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gerson M Pereira Junior, MD</last_name>
      <phone>5531992134768</phone>
      <email>gersonmpj@yahoo.com.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical School of Botucatu of the Paulista State University - UNESP</name>
      <address>
        <city>Rubiao Junior</city>
        <state>Botucatu</state>
        <zip>18618-687</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Cuadrado Martin, MD</last_name>
      <phone>551438801171</phone>
      <email>cuadrado@fmb.unesp.br</email>
    </contact>
    <investigator>
      <last_name>Luis Cuadrado Martin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fundacao Pro-Rim</name>
      <address>
        <city>Boa Vista</city>
        <state>Joinville</state>
        <zip>89227680</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viviane Calice-Silva, MD</last_name>
      <phone>5547991534003</phone>
      <email>vivicalice@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Felicio Rocho Foundation - Hospital Felicio Rocho</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30110934</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marisa F Ferreira, MD</last_name>
      <phone>553135147195</phone>
      <email>marisafferreira@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacao Hospitalar Sao Francisco de Assis</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>31110580</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geraldo M Medeiros de Paula, MD</last_name>
      <phone>5531983031600</phone>
      <email>geraldo_paula@uol.com.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Servico Ubaense de Nefrologia Ltda</name>
      <address>
        <city>Uba</city>
        <state>Minas Gerais</state>
        <zip>36500008</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ricardo F Carvalho, MD</last_name>
      <phone>3235314046</phone>
      <email>ricardofurtadodecarvalho@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eurolatino Natal Pesquisas Medicas Ltda</name>
      <address>
        <city>Petropolis</city>
        <state>Natal</state>
        <zip>59020500</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria S Moura de Oliveira Paiva, MD</last_name>
      <phone>8499188732</phone>
      <email>msanali@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sociedade Hospitalar Angelina Caron</name>
      <address>
        <city>Campina Grande Do Sul</city>
        <state>Parana</state>
        <zip>83430000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dalton B Precoma, MD</last_name>
      <phone>554136798783</phone>
      <email>daltonprecoma@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Pro Renal Brazil</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80440-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miguel Carlos Riella, MD</last_name>
      <email>mcriella@pro-renal.org.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA</name>
      <address>
        <city>Bairro Santa Teresa</city>
        <state>Porto Alegre</state>
        <zip>90020090</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joao C Goldani, MD</last_name>
      <phone>555132148640</phone>
      <email>jcgoldani@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernando Thome, MD</last_name>
      <email>fthome@hcpa.edu.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Arquidiocesano Consul Carlos Reneaux</name>
      <address>
        <city>Brusque</city>
        <state>Santa Catarina</state>
        <zip>8835404</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antonio de Padua Lanna, MD</last_name>
      <email>antoniopslanna@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sociedade Campineira de Educacao e Instrucao (SCEI)</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13034-685</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aloisio Marchi da Rocha, MD</last_name>
      <email>am.rocha@uol.com.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Praxis Pesquisa Medica S/S</name>
      <address>
        <city>Santo André</city>
        <state>Sao Paulo</state>
        <zip>09090 790</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcelo R Bacci, MD</last_name>
      <phone>551127598377</phone>
      <email>mrbacci@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Votuporanga</name>
      <address>
        <city>Votuporanga</city>
        <state>Sao Paulo</state>
        <zip>15500003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro E Hernandes, MD</last_name>
      <email>Maurohernandes0@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>PROCARDIO Clinica Cardiologica</name>
      <address>
        <city>Blumenau</city>
        <state>SC</state>
        <zip>89010500</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio L Zimmermann, MD</last_name>
      <phone>554732223667</phone>
      <email>slzimmermann@cardioblu.com.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Foothills Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Braden Manns, MD</last_name>
      <phone>403-944-2595</phone>
      <phone_ext>4120</phone_ext>
      <email>braden.manns@albertahealthservices.ca</email>
    </contact>
    <investigator>
      <last_name>Braden Manns, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neesh Pannu, MD</last_name>
      <phone>780-407-8520</phone>
      <email>npannu@ualberta.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr.J. Conley</name>
      <address>
        <city>Kamloops</city>
        <state>British Colombia</state>
        <zip>V2C 2T1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joslyn Conley, MD</last_name>
      <phone>7782572509</phone>
      <email>Joslyn.Conley@interiorhealth.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr. Marie Michaud</name>
      <address>
        <city>Kelowna</city>
        <state>British Colombia</state>
        <zip>V1Y 1T2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Michaud, MD</last_name>
      <phone>7782572509</phone>
      <email>marie.michaud@interiorhealth.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Colombia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mercedeh Kiaii, MD</last_name>
      <phone>604-682-2344</phone>
      <phone_ext>62232</phone_ext>
      <email>mkiaii@providencehealth.bc.ca</email>
    </contact>
    <investigator>
      <last_name>Mercedeh Kiaii, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Science Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karthik Tennankore, MD</last_name>
      <phone>9024732099</phone>
      <email>karthikK.Tennankore@nshealth.ca</email>
    </contact>
    <contact_backup>
      <last_name>Steven D Soroka, MD</last_name>
      <phone>9024732099</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Rabbat, MD</last_name>
      <phone>9055221155</phone>
      <phone_ext>33542</phone_ext>
      <email>rabbatc@mcmaster.ca</email>
    </contact>
    <contact_backup>
      <last_name>Scott Brimble, MD</last_name>
      <phone>9055221155</phone>
      <phone_ext>33787</phone_ext>
      <email>brimbles@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Queen's University at Kingston, Division of Nephrology</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin K Thomson, MD</last_name>
      <phone>613-533-6000</phone>
      <phone_ext>74500</phone_ext>
      <email>benjamin.thomson@kingstonhsc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Weir, MD</last_name>
      <phone>519-685-8502</phone>
      <email>matthew.weir@lhsc.on.ca</email>
    </contact>
    <investigator>
      <last_name>Matthew Weir, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debra Zimmerman, MD</last_name>
      <email>dzimmerman@toh.on.ca</email>
    </contact>
    <investigator>
      <last_name>Debra Zimmerman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Health Sciences North Research Institute</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John P Harmon, MD</last_name>
      <phone>702-523-7300</phone>
      <phone_ext>2634</phone_ext>
      <email>jharmon@hsnsudbury.ca</email>
    </contact>
    <contact_backup>
      <last_name>Amy Nistico, MD</last_name>
      <phone>705-523-7300</phone>
      <phone_ext>3900</phone_ext>
      <email>anistico@hsnsudbury.ca</email>
    </contact_backup>
    <investigator>
      <last_name>John P Harmon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ron Wald, MD</last_name>
      <phone>416-864-3703</phone>
      <email>waldr@smh.ca</email>
    </contact>
    <investigator>
      <last_name>Ron Wald, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dr. Joanna Sasal</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6R 1B5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Sasal, MD</last_name>
      <phone>4165306772</phone>
      <email>JSasal@stjoestoronto.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr. Annie-Claire Nadeau-Fredette</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annie-Claire Nadeau-Fredette, MD</last_name>
      <email>acnadeau-fredette.hmr@ssss.qouv.qc.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital du Sacre-Coeur de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francois Madore, MD</last_name>
      <phone>514-338-2222</phone>
      <phone_ext>2491</phone_ext>
      <email>f.madore@umontreal.ca</email>
    </contact>
    <investigator>
      <last_name>Francois Madore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Universite de Montreal (CHUM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2W 1T8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rita Suri, MD</last_name>
      <phone>514-890-800</phone>
      <phone_ext>36369</phone_ext>
      <email>rsuri.kidney@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Rita Suri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec L'Hotel-Dieu de Quebec</name>
      <address>
        <city>Québec</city>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sacha DeSerres, MD</last_name>
      <phone>418-691-5464</phone>
      <email>sacha.DeSerres@crchudequebec.ulaval.ca</email>
    </contact>
    <investigator>
      <last_name>Sacha DeSerres, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nefrology</name>
      <address>
        <city>Quito</city>
        <state>Pichincha</state>
        <zip>170131</zip>
        <country>Ecuador</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinefnorte CIA Ltda</name>
      <address>
        <city>Quito</city>
        <state>Pichincha</state>
        <zip>170303</zip>
        <country>Ecuador</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Santiago Carrasco, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Doris Almeida, MD</last_name>
      <email>doryvon@hotmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Nefromedi SA</name>
      <address>
        <city>Quito</city>
        <state>Pichincha</state>
        <zip>170601</zip>
        <country>Ecuador</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mayra Sanchez Velez, MD</last_name>
      <email>mayrisanzvelez@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Madras Medical College Chennai</name>
      <address>
        <city>Park Town</city>
        <state>Chennai</state>
        <zip>600003</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Natarajan Gopalakrishnan, MD</last_name>
      <phone>9444085404</phone>
      <email>srigola751@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CBCI Society for Medical Education</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560034</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ravishankar Bonu, MD</last_name>
      <email>ravibonu@yahoo.co.in</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Narayana Hrudayalaya Limited</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560099</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ram M Bhatt, MD</last_name>
      <phone>919731285588</phone>
      <email>docrambhat@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fortis Hospitals</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560076</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rajanna Sreedhara, MD</last_name>
      <phone>9880150813</phone>
      <email>rsreedhara@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>K S Hegde Medical Academy</name>
      <address>
        <city>Mangaluru</city>
        <state>Karnataka</state>
        <zip>575018</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pradeep Shenoy, MD</last_name>
      <email>mpradeepshenoy@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjappa Hospitals Shimoga</name>
      <address>
        <city>Shimoga</city>
        <state>Karnataka</state>
        <zip>577201</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Y Anupama, MD</last_name>
      <email>anupamayj@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AsterMedCity</name>
      <address>
        <city>Cochin</city>
        <state>Kerala</state>
        <zip>682027</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Caritas Hospital</name>
      <address>
        <city>Kottayam</city>
        <state>Kerala</state>
        <zip>686630</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gopin Suresh, MD</last_name>
      <email>gopinathsuresh@rediffmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AIMS Hospital Mumbai</name>
      <address>
        <city>Dombivli</city>
        <state>Maharashtra</state>
        <zip>421203</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sachlin Gupta, MD</last_name>
      <email>ssg_sachin@yahoo.ca.in</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Health and Education Society</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400016</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Alan F Almeida, MD</last_name>
      <phone>912224447612</phone>
      <email>almeidaa@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ashirwad Hospital Mumbai</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>421004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hardik Shah, MD</last_name>
      <phone>09833919767</phone>
      <email>drhardik74@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dhadiwal Hospital</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>ACE Hospital Une</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Atul Sajgure, MD</last_name>
      <phone>9890676278</phone>
      <email>dratulsajgure@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aditya Birla Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411033</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tarun Jeloka, MD</last_name>
      <phone>919670691221</phone>
      <email>tjeloka@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vijaya Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600026</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radha Venkatramanan, MD</last_name>
      <email>radhavenkatramanan@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Apollo Hospitals</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600081</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Visweswar Reddy, MD</last_name>
      <phone>04425911111</phone>
      <email>rishikeshsangeetha@yahoo.co.in</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mahatma Gandhi Medical College and Reserach Institute</name>
      <address>
        <city>Puducherry</city>
        <state>Tamil Nadu</state>
        <zip>607402</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hemachandar, MD</last_name>
      <email>nephrology@mgmcri.ac.in</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nizam's Institute of Medical Sciences</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sree B Raju, MD</last_name>
      <phone>9848492951</phone>
      <email>sreebhushan@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yashoda Hospital</name>
      <address>
        <city>Susundra</city>
        <state>Telangana</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Urmila Anandh, MD</last_name>
      <email>uanandh@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Osmania General Hospital</name>
      <address>
        <city>Hyderabad</city>
        <state>Telegana</state>
        <zip>500012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manisha Sahay, MD</last_name>
      <email>drmanishasahay@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Sultanah Aminah, Johor Bahru</name>
      <address>
        <city>Johor Bahru</city>
        <state>Johor</state>
        <zip>80100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen J Liu, MD</last_name>
      <email>plnjl@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Pakar Sultanah Fatimah</name>
      <address>
        <city>Muar</city>
        <state>Johor</state>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mah Doo Yee, MD</last_name>
      <email>mahdy426@yahoo.com.sg</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universiti Kebangsaan Malaysia</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital Raja Permaisuri Bainun, IPOH</name>
      <address>
        <city>Ipoh</city>
        <state>Perak</state>
        <zip>30990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital Taiping</name>
      <address>
        <city>Taiping</city>
        <state>Perak</state>
        <zip>34000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teng K Seng, MD</last_name>
      <email>tgks79@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang</name>
      <address>
        <city>George Town</city>
        <state>Pulau Pinang</state>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>:oew Yew Fong, MD</last_name>
      <email>lyewfong@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universiti Teknologi Mara (UiTM)</name>
      <address>
        <city>Batu Caves</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital Kajang</name>
      <address>
        <city>Kajang</city>
        <state>Selangor</state>
        <zip>43000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sadanah A Mazlan, MD</last_name>
      <email>sadanahmazlan@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Tengku Ampuan Rahimah Klang</name>
      <address>
        <city>Klang</city>
        <state>Selangor</state>
        <zip>41200</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shahnaz Shah Firdaus Khan, MD</last_name>
      <email>shahsfkhan@yahoo.com.sg</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Kuala Lumpur</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>42896</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wan Hazlina wan Mohamad, MD</last_name>
      <email>hazlina2080@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre (UMMC)</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hafiz Adnan, MD</last_name>
      <email>wahafiz@ummc.edu.my</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Sultanah Nur Zahirah Kuala Terengganu</name>
      <address>
        <city>Kuala Terengganu</city>
        <zip>33158</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaiha Harun, MD</last_name>
      <email>zaiharun@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Tengku Ampuan Afzan, Kuantan</name>
      <address>
        <city>Kuantan</city>
        <zip>29142</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohd Kamil Ahmad, MD</last_name>
      <email>mkaz_77@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Tuanku Jaafar, Seremban</name>
      <address>
        <city>Seremban</city>
        <zip>25167</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lily Mushahar, MD</last_name>
      <email>lilymushahar@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Ampang</name>
      <address>
        <city>Setapak</city>
        <zip>53200</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norazinizah Miswan, MD</last_name>
      <email>norazinizah@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital</name>
      <address>
        <city>Takapuna</city>
        <state>Auckland</state>
        <zip>0620</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janak de Zoysa, MD</last_name>
      <email>janak.dezoysa@waitematadhb.govt.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Waikato</state>
        <zip>3204</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kannaiyan Rabindranath, MD</last_name>
      <email>k.rabindranath@waikatodhb.health.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracey Putt, MD</last_name>
      <email>tracey.putt@southerndhb.govt.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hawkes Bay Hospital</name>
      <address>
        <city>Hastings</city>
        <zip>4120</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew McNally, MD</last_name>
      <email>andrew.mcnally@hawkesbaydhb.govt.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taranaki Base Hospital</name>
      <address>
        <city>New Plymouth</city>
        <zip>4310</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Palmerston North Hospital</name>
      <address>
        <city>Palmerston North</city>
        <zip>4442</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norman Panlilio, MD</last_name>
      <email>norman.panlilio@midcentraldhb.govt.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Whangarei Hospital</name>
      <address>
        <city>Whangarei</city>
        <zip>0148</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam Mullan, MD</last_name>
      <email>adam.mullan@northlanddhb.org.nz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Philippines General Hospital</name>
      <address>
        <city>Ermita</city>
        <state>Manila</state>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rey Tan, MD</last_name>
      <phone>92850330987</phone>
      <email>reyjaimetan@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical City General Hospital</name>
      <address>
        <city>Pasig City</city>
        <state>Manila</state>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>National Kidney and Transplant Institute</name>
      <address>
        <city>Quezon City</city>
        <state>Manila</state>
        <zip>1101</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony R Villanueva, MD</last_name>
      <phone>9178390041</phone>
      <email>villanueva.russ@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ulster Hospital</name>
      <address>
        <city>Dundonald</city>
        <state>Belfast</state>
        <zip>BT16 1RH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alastair Woodman</last_name>
      <email>alastair.woodman@setrust.hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Daisy Hill Hospital</name>
      <address>
        <city>Newry</city>
        <state>Down</state>
        <zip>BT35 8DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neal Morgan</last_name>
      <email>neal.morgan@southerntrust.hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kent &amp; Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <state>Kent</state>
        <zip>CT1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Timothy Doulton</last_name>
      <email>tdoulton@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edward Sharples</last_name>
      <email>edward.sharples@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB23 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shona Methven</last_name>
      <email>shona.methven@nhs.scot</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Hill</last_name>
      <email>christopher.hill@belfasttrust.hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albert Power</last_name>
      <email>albert.power@nbt.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Whales Health Park</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rhodri Pyart</last_name>
      <email>rhodri.pyart@wales.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Derby Hospital</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nick Selby</last_name>
      <email>nick.selby@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samira Bell</last_name>
      <email>samira.bell@nhs.scot</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth University Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Mark</last_name>
      <email>patrick.mark@glasgow.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Rajan Patel</last_name>
      <email>rajan.patel@ggc.scot.nhs.uk</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The Royal London Hospital</name>
      <address>
        <city>London</city>
        <zip>E1 2ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kieran McCafferty</last_name>
      <email>kieran.mccafferty4@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kate Bramham</last_name>
      <email>kate.bramham@kcl.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>City Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Jesky</last_name>
      <email>mark.jesky@nuh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Salford Royal Hospital</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rajkumar Chinnadurai</last_name>
      <email>rajkumar.chinnadurai@nca.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Canimel Center</name>
      <address>
        <city>Melo</city>
        <state>Cerro Largo</state>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pilar Varela, MD</last_name>
      <phone>598099690412</phone>
      <email>varela_pilar@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas &quot;Dr. Manuel Quintela&quot;</name>
      <address>
        <city>Montevideo</city>
        <zip>11600</zip>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ricardo Silvarino, MD</last_name>
      <phone>59899619401</phone>
      <email>rsilvarino@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>SEDIC Center</name>
      <address>
        <city>Montevideo</city>
        <zip>11800</zip>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Miller, MD</last_name>
      <phone>24871581</phone>
      <email>elvaca33@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cedina Center</name>
      <address>
        <city>Montevideo</city>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan C Diaz, MD</last_name>
      <phone>59894400364</phone>
      <email>jcdiazsalvia@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)</name>
      <address>
        <city>Montevideo</city>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Sola, MD</last_name>
      <email>solalaura11@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Ecuador</country>
    <country>India</country>
    <country>Malaysia</country>
    <country>New Zealand</country>
    <country>Philippines</country>
    <country>United Kingdom</country>
    <country>Uruguay</country>
  </location_countries>
  <removed_countries>
    <country>Colombia</country>
  </removed_countries>
  <reference>
    <citation>Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.</citation>
    <PMID>27265777</PMID>
  </reference>
  <reference>
    <citation>Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.</citation>
    <PMID>26138259</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spironolactone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A - no plan to make IPD available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03020303
org study id: ACHIEVE
nct id: NCT03020303
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Individuals receiving dialysis are at risk of heart failure and heart related death. There is
      an urgent need for treatments that reduce the risk of these problems in patients that require
      dialysis.

      Spironolactone is a pill used to prevent heart failure and related deaths in patients that do
      not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes
      high blood pressure and can damage the heart. Although spironolactone is very effective in
      patients that do not require dialysis, we do not know if spironolactone is effective in
      dialysis patients. Our research will help determine if spironolactone reduces heart failure
      and heart related deaths in dialysis patients.

      The purpose of this study is to determine if spironolactone reduces death or hospitalization
      for heart failure and is well tolerated in patients that require dialysis.
Globally, over 2 million people receive dialysis for end-stage renal disease (ESRD) and
      650,000 new patients start dialysis each year. Furthermore, the number of patients receiving
      dialysis is increasing as access to dialysis in the developing world improves and the
      prevalence of diabetes and vascular disease rises. Despite technical advances in dialysis,
      the outcomes for patients with ESRD are poor. Patients have frequent hospitalizations, poor
      health related quality of life and strikingly, high mortality rates.

      The most common cause of death in patients receiving dialysis is cardiovascular disease,
      accounting for >40% of all deaths. Observational studies suggest a causal pathway to
      cardiovascular death that includes progressive ventricular hypertrophy and dilatation as well
      as accelerated atherosclerosis. These changes result in myocardial ischemia and cardiac
      fibrosis that, in turn, lead to heart failure, arrhythmias and cardiac arrest. Strongly
      implicated in this pathophysiology is aldosterone. Mineralocorticoid receptor antagonists
      (MRAs) in non-ESRD patients, prevent cardiovascular deaths and small randomized controlled
      trials of MRAs in ESRD suggests they may reduce death and may be safe.

      Spironolactone is the most commonly used MRA worldwide. We will conduct a multicentre
      randomized controlled trial (RCT) to determine if spironolactone reduces cardiac mortality
      and hospitalizations for heart failure in patients treated with dialysis. This trial is
      called the Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease
      (ACHIEVE).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: CV Death or Hospitalization for Heart Failure
time frame: up to 5 years
measure: Cause specific death
time frame: up to 5 years
measure: Hospitalization for Heart Failure
time frame: up to 5 years
measure: All-cause death
time frame: up to 5 years
measure: All-cause Hospitalization
time frame: up to 5 years
measure: Hospitalization for hyperkalemia
time frame: up to 5 years
arm group label: Placebo Oral Tablet
arm group type: Placebo Comparator
description: A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance
arm group label: Spironolactone 25 MG Tablet
arm group type: Active Comparator
description: 25 mg of active spironolactone in tablet form
intervention type: Drug
intervention name: Spironolactone 25Mg Tablet
description: Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
arm group label: Spironolactone 25 MG Tablet
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.
arm group label: Placebo Oral Tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Walsh, MD, PhD
role: Principal Investigator
affiliation: McMaster University
last name: PJ Devereaux, MD, PhD
role: Study Chair
affiliation: McMaster University
last name: Jessica Tyrwhitt, B.A.
phone: 9055274322
phone ext: 40555
email: jessica.tyrwhitt@phri.ca
last name: Colin Hardy, B.A.
phone: 9055274322
phone ext: 40694
email: colin.hardy@phri.ca
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Australia
country: Brazil
country: Canada
country: Ecuador
country: India
country: Malaysia
country: New Zealand
country: Philippines
country: United Kingdom
country: Uruguay
country: Colombia
citation: Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.
PMID: 27265777
citation: Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.
PMID: 26138259
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Spironolactone
sharing ipd: No
ipd description: N/A - no plan to make IPD available to other researchers