<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/NCT04507061</url>
  </required_header>
  <id_info>
    <org_study_id>18748</org_study_id>
    <secondary_id>2019-003297-53</secondary_id>
    <nct_id>NCT04507061</nct_id>
  </id_info>
  <brief_title>Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.</brief_title>
  <acronym>CONCORD</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Individually Titrated Oral Doses of Runcaciguat in Subjects With Clinical Diagnosis of Chronic Kidney Disease With Diabetes and/or Hypertension and at Least One Cardiovascular Comorbidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers in this study want to learn more about the safety of the drug runcaciguat and how&#xD;
      well it works when given at the highest dose as tolerated by the individual patient whose&#xD;
      kidneys are not working properly and suffering at the same time from high blood sugar and/or&#xD;
      high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new&#xD;
      drug under development for the improvement of kidney function. It works by activating&#xD;
      proteins that helps to dilate blood vessels, including vessels in the kidneys. This can&#xD;
      improve blood flow in kidney and may slow down the progression of kidney disease. This&#xD;
      dilative effect can also influence the heart rate and blood pressure. Researchers also wants&#xD;
      to find the best dose of the drug during the study.&#xD;
&#xD;
      Participants in this study will receive either runcaciguat or placebo tablets every morning&#xD;
      for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it.&#xD;
      On a weekly basis, the dose of the runcaciguat will be increased step by step. In total,&#xD;
      participants will visit the doctors about 10 times, and the observation will last for about&#xD;
      16 weeks. Blood and urine samples will collected from the participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">April 5, 2022</completion_date>
  <primary_completion_date type="Actual">March 8, 2022</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment</measure>
    <time_frame>From baseline up to day 57 (± 3)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with treatment emergent adverse event (TEAE)</measure>
    <time_frame>From first treatment administration up to end of follow up (Day 87±7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with early discontinuations</measure>
    <time_frame>From first treatment administration up to end of treatment (Day 57±3)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>runcaciguat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant randomized to this arm will be up-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant randomized to this arm will be sham-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>runcaciguat</intervention_name>
    <description>Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.</description>
    <arm_group_label>runcaciguat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sham-titrated dose of matching placebo will be administered orally once a day.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age - Participant must be ≥ 45 of age inclusive, at the time of signing the informed&#xD;
        consent.&#xD;
&#xD;
        Type of Participant and Disease Characteristics&#xD;
&#xD;
        - Participants who have:&#xD;
&#xD;
          -  history of any of the following:&#xD;
&#xD;
               -  type 2 diabetes mellitus as defined by the American Diabetes Association (on&#xD;
                  treatment with glucose-lowering medications and/or insulin) for at least 2 years,&#xD;
                  and/or;&#xD;
&#xD;
               -  diagnosis of hypertension (defined as systolic blood pressure [BP] values ≥ 140&#xD;
                  mmHg and/or diastolic BP values ≥90 mmHg) and on hypertension medication for at&#xD;
                  least 5 years;&#xD;
&#xD;
          -  established atherosclerotic cardiovascular disease (e.g. coronary artery disease,&#xD;
             peripheral arterial disease, cerebrovascular disease) or heart failure;&#xD;
&#xD;
          -  a clinical diagnosis of chronic kidney disease (CKD) based on all of the following&#xD;
             criteria:&#xD;
&#xD;
               -  (estimated) glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m^2 but ≤ 60&#xD;
                  mL/min/1.73 m^2 (acc. Percentage of decrease in eGFR [CKD EPI]);&#xD;
&#xD;
               -  persistent high albuminuria defined as urine albumin-to-creatinine ratio [UACR]&#xD;
                  of between 30 mg/g and 3000 mg/g in 2 first morning void samples (collected at&#xD;
                  least 1 week apart);&#xD;
&#xD;
               -  Stable treatment with angiotensin-converting enzyme inhibitor (ACEi) or&#xD;
                  angiotensin-receptor blocker (ARB) for the participant maximum tolerated labelled&#xD;
                  daily dose and otherwise stable antihypertensive treatment both for at least 3&#xD;
                  months before randomization, without any adjustments to this therapy for at least&#xD;
                  4 weeks prior to randomization;&#xD;
&#xD;
          -  Diabetes patients that are on SGLT2-inhibitor (SGLT: sodium glucose transport protein)&#xD;
             have to be on stable treatment for at least 3 months before Screening visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known non-diabetic and non-hypertension related renal diseases as autosomal dominant&#xD;
             polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus&#xD;
             nephritis, or ANCA-associated vasculitis, IgA nephropathy without hypertension, or any&#xD;
             other secondary glomerulonephritis;&#xD;
&#xD;
          -  Clinical diagnoses of heart failure and persistent symptoms (New York Heart&#xD;
             Association (NYHA class III - IV);&#xD;
&#xD;
          -  Uncontrolled hypertension indicated by &gt;160 mmHg systolic BP or ≥ 100 mmHg diastolic&#xD;
             BP;&#xD;
&#xD;
          -  History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism,&#xD;
             or pheochromocytoma);&#xD;
&#xD;
          -  Stroke, transient ischemic cerebral attack, acute coronary syndrome, or&#xD;
             hospitalization for worsening heart failure, in the last 3 months prior to the planned&#xD;
             randomization;&#xD;
&#xD;
          -  Dialysis for acute renal failure within the previous 6 months prior to the planned&#xD;
             randomization;&#xD;
&#xD;
          -  Renal allograft in place or a scheduled kidney transplant within the next 18 weeks&#xD;
             (being on a waiting list does not exclude the subject);&#xD;
&#xD;
          -  Hepatic insufficiency classified as Child-Pugh B or C or other significant liver&#xD;
             disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by&#xD;
             e.g. aspartate aminotransferase [AST] or Alanine aminotransferase [ALT] &gt;3x upper&#xD;
             limit of norm [ULN]);&#xD;
&#xD;
          -  Active malignancy other than treated squamous cell, carcinoma in situ, or basal cell&#xD;
             carcinoma of the skin Prior/Concomitant Therapy;&#xD;
&#xD;
          -  Any surgical or medical condition, which in the opinion of the investigator, may place&#xD;
             the patient at higher risk from his/her participation in the study, or is likely to&#xD;
             prevent the patient from complying with the requirements of the study or completing&#xD;
             the study including but not limited to:&#xD;
&#xD;
               1. History of active inflammatory bowel disease within the last 6 months before&#xD;
                  randomization;&#xD;
&#xD;
               2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or&#xD;
                  bowel resection;&#xD;
&#xD;
               3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6&#xD;
                  months before randomization;&#xD;
&#xD;
               4. Pancreatic injury or pancreatitis within the last 6 months before randomization;&#xD;
&#xD;
          -  Non diabetic patients treated with SGLT-2 (SGLT:sodium glucose transport protein)&#xD;
             inhibitors;&#xD;
&#xD;
          -  Combination use of ACEi and ARB within 3 months prior to randomization;&#xD;
&#xD;
          -  Concomitant therapy with nitrates, PDE5 inhibitors including nonspecific inhibitors&#xD;
             (e.g. dipyridamole and theophylline), soluble guanylate cyclase [sGC] stimulators,&#xD;
             renin inhibitors (within 4 weeks prior to randomization);&#xD;
&#xD;
          -  Participation in another clinical study or treatment with another investigational&#xD;
             product 90 days prior to randomization;&#xD;
&#xD;
          -  Previous randomization in this study;&#xD;
&#xD;
          -  hemoglobin A1c (HbA1c) &gt;11%;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Landstraße - Krankenhaus Rudolfstiftung</name>
      <address>
        <city>Wien</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum f. klinische Studien Dr. Hanusch GmbH</name>
      <address>
        <city>Wien</city>
        <zip>1060</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum AKH Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Hietzing</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OL Vrouwziekenhuis - Campus Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme/Erasmus Ziekenhuis</name>
      <address>
        <city>Bruxelles - Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Centre Diamedical 2013</name>
      <address>
        <city>Dimitrovgrad</city>
        <zip>6400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Medline Clinic</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Sveta Karidad</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr. Bratan Shukerov AD</name>
      <address>
        <city>Smolyan</city>
        <zip>4700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Knyaginya Klementina - Sofia&quot;EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Kalimat</name>
      <address>
        <city>Sofia</city>
        <zip>1680</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCOMH Preventsia-2000</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Region Nordjylland | Aalborg University Hospital - Cardiology Department</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steno Diabetes Center Copenhagen</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionshospitalet Gødstrup</name>
      <address>
        <city>Herning</city>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holbæk Sygehus</name>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital, Endokrinologisk Afd. M</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>StudyCor Oy</name>
      <address>
        <city>Jyväskylä</city>
        <zip>40620</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnos Klaukkalan Lääkäriasema</name>
      <address>
        <city>Klaukkala</city>
        <zip>01800</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Satucon / Kuopion Työterveys</name>
      <address>
        <city>Kuopio</city>
        <zip>70100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omena Terveys Oy</name>
      <address>
        <city>Seinäjoki</city>
        <zip>60320</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turun yliopistollinen keskussairaala</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Würzburg</name>
      <address>
        <city>Wuerzburg</city>
        <state>Bayern</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Clinical Research Deutschland GmbH</name>
      <address>
        <city>Duesseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>InnoDiab Forschung GmbH</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medamed Studienambulanz GmbH</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04315</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center | Nephrology &amp; Hypertension Dept.</name>
      <address>
        <city>Ashkelon</city>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lady Davis Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Hospital Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Corporation of Galilee Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clalit Health Services Rabin Medical Center-Beilinson Campus</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poriya Medical Center | Nephrology and Hypertension Dept.</name>
      <address>
        <city>Tiberius</city>
        <zip>1528001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Luigi Vanvitelli</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. di Bologna Policlinico S.Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Ricerche Farmacologiche Mario Negri IRCCS</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele s.r.l.</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro Cardiologico Monzino S.p.A</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSWiA w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FMC-dialyzacne sluzby, s.r.o. - Kosice</name>
      <address>
        <city>Kosice</city>
        <zip>040 11</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BIODIAL, spol. s r.o.</name>
      <address>
        <city>Puchov</city>
        <zip>020 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medivasa s.r.o.</name>
      <address>
        <city>Zilina</city>
        <zip>01001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial</name>
      <address>
        <city>Ferrol</city>
        <state>A Coruña</state>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hosp. Univ. A Coruña | Endocrinologia y Nutricion</name>
      <address>
        <city>A Coruña</city>
        <zip>150006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitaria i Universitaria de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quirón</name>
      <address>
        <city>Barcelona</city>
        <zip>08023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves|Medicina Interna</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PTC-Primary care Trial Center</name>
      <address>
        <city>Göteborg</city>
        <zip>413 46</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clemenstorget Hjärtmottagning</name>
      <address>
        <city>Lund</city>
        <zip>222 21</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset Njurmottagningen</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSmart</name>
      <address>
        <city>Uppsala</city>
        <zip>752 37</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center LLC &quot; Fresenius medical care Ukraine&quot;</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnepropetrovsk regional hospital n.a. I. I. Mechnikov</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private enterprise private production company &quot; Acinus&quot;</name>
      <address>
        <city>Kropyvnytskyi</city>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Center of Nephrology and Dialysis</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of Edelweiss Medics LLC</name>
      <address>
        <city>Kyiv</city>
        <zip>02002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Center of Nephrology and Dialysis</name>
      <address>
        <city>Kyiv</city>
        <zip>02660</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volyn Regional Clinical Hospital</name>
      <address>
        <city>Lutsk</city>
        <zip>43005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ternopil Regional Clinical Hospital</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaporizhzhia Regional Clinical Hospital</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Ukraine</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe.</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 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>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access.&#xD;
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</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/NCT04507061
org study id: 18748
secondary id: 2019-003297-53
nct id: NCT04507061
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Researchers in this study want to learn more about the safety of the drug runcaciguat and how
      well it works when given at the highest dose as tolerated by the individual patient whose
      kidneys are not working properly and suffering at the same time from high blood sugar and/or
      high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new
      drug under development for the improvement of kidney function. It works by activating
      proteins that helps to dilate blood vessels, including vessels in the kidneys. This can
      improve blood flow in kidney and may slow down the progression of kidney disease. This
      dilative effect can also influence the heart rate and blood pressure. Researchers also wants
      to find the best dose of the drug during the study.

      Participants in this study will receive either runcaciguat or placebo tablets every morning
      for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it.
      On a weekly basis, the dose of the runcaciguat will be increased step by step. In total,
      participants will visit the doctors about 10 times, and the observation will last for about
      16 weeks. Blood and urine samples will collected from the participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment
time frame: From baseline up to day 57 (± 3)
measure: Number of subjects with treatment emergent adverse event (TEAE)
time frame: From first treatment administration up to end of follow up (Day 87±7)
measure: Number of subjects with early discontinuations
time frame: From first treatment administration up to end of treatment (Day 57±3)
arm group label: runcaciguat
arm group type: Experimental
description: Participant randomized to this arm will be up-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participant randomized to this arm will be sham-titrated. A 30-day safety follow up will be performed after end of treatment or after early discontinuation from the study.
intervention type: Drug
intervention name: runcaciguat
description: Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.
arm group label: runcaciguat
intervention type: Other
intervention name: Placebo
description: Sham-titrated dose of matching placebo will be administered orally once a day.
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Austria
country: Belgium
country: Bulgaria
country: Denmark
country: Finland
country: Germany
country: Israel
country: Italy
country: Poland
country: Slovakia
country: Spain
country: Sweden
country: Ukraine
url: https://clinicaltrials.bayer.com/
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.