<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/NCT03806452</url>
  </required_header>
  <id_info>
    <org_study_id>SIK-FR-17-1</org_study_id>
    <nct_id>NCT03806452</nct_id>
  </id_info>
  <brief_title>SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)</brief_title>
  <acronym>SIKAMIC</acronym>
  <official_title>Multicentre Randomized Double-blind Placebo-controlled Study to Evaluate the Effect on Albuminuria of 6 Months Treatment With Hydroxycarbamide (Siklos®) or a Placebo in Adults With Sickle Cell Disease:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ADDMEDICA SASA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ADDMEDICA SASA</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>
      The purpose of this phase IIb, international, multicentre, double-blind, randomised,&#xD;
      placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after&#xD;
      6 months of treatment in SCD adult patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients achieving at least a 30% decrease in ACR baseline value</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in eGFR value</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in ACR value</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a shift from macroalbuminuria to microalbuminuria</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a shift from microalbuminuria to normoalbuminuria</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a shift from macroalbuminuria to normoalbuminuria</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a shift from microalbuminuria to macroalbuminuria</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution curve of ACR</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution curve of ACR</measure>
    <time_frame>From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution curve of eGFR</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution curve of eGFR</measure>
    <time_frame>From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of clinical markers associated with response to treatment.</measure>
    <time_frame>6 months</time_frame>
    <description>Reported any sickle cell disease related organopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of biological markers associated with response to treatment.</measure>
    <time_frame>6 months</time_frame>
    <description>Haematology: Red blood cell count and Mean Corpuscular Volume, Dense Red Blood Cells, reticulocytes, Hemoglobin, free Hemoglobin and Fetal hemoglobin, Mean Corpuscular Hemoglobin and Mean Corpuscular Hemoglobin Concentration, hematocrit, White Blood Cell counts, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet counts, endogenous EPO and ferritin concentrations.&#xD;
Blood biochemistry : Renal function: blood Creatinine. Haemolysis biochemical markers: Lactate Deshydrogenase, aspartate aminotransferase, ALT, BUN, conjugated and total bilirubin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent AEs and SAEs</measure>
    <time_frame>Through study completion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes of systolic blood pressure</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes of body mass index</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes of diastolic blood pressure</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes of heart rate measure</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in white blood cells count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in platelets count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in mean corpuscular volume</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in mean corpuscular haemoglobin concentration</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in mean corpuscular haemoglobin</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in hemoglobin count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in foetal hemoglobin count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in free hemoglobin count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in Dense red blood cells percentage</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in endogenous erythropoietin count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in ferritin count</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in lactate dehydrogenase</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in Aspartate aminotransferase</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in Alanine Amino Transferase</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in blood urea nitrogen</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in conjugated bilirubin</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in total bilirubin</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute mean changes in reticulocytes</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of SCD-related clinical events</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers predictive of SCN (only French patients)</measure>
    <time_frame>6 months and 12 months for responder patients willing to continue the study after month 6.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Hydroxycarbamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydroxycarbamide will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Hydroxycarbamide will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.&#xD;
Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Placebo will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.&#xD;
Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxycarbamide</intervention_name>
    <description>Hydroxycarbamide tablets of 100 and 1000 mg</description>
    <arm_group_label>Hydroxycarbamide</arm_group_label>
    <other_name>Siklos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated Informed Consent Form (ICF) by a legally competent patient.&#xD;
&#xD;
          2. Patients above 18 years.&#xD;
&#xD;
          3. Patients with HbSS or HbSβ0 SCD.&#xD;
&#xD;
          4. Patients with a value of albuminuria, assessed by ACR, over 3 mg/mmol and inferior to&#xD;
             100 mg/mmol confirmed by 3 positive urine samples taken one day apart.&#xD;
&#xD;
          5. Female patients of childbearing potential or postmenopausal female with last period &lt;&#xD;
             12 months before screening agreeing to use a highly effective form of contraception&#xD;
             (oral, injected or implanted hormonal contraception, intrauterine device, diaphragm,&#xD;
             condom) during the trial and for 3 months after hydroxycarbamide discontinuation.&#xD;
&#xD;
          6. Male patients with partners of childbearing potential agreeing to use a highly&#xD;
             effective contraception during the trial and for 3 months after hydroxycarbamide&#xD;
             discontinuation. Men with pregnant or lactating women should be advised to use a&#xD;
             barrier method of contraception (condom) to prevent the foetus or breastfed infant&#xD;
             from exposure to hydroxycarbamide.&#xD;
&#xD;
          7. Patients who are covered by insurance scheme according to local regulatory&#xD;
             requierements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks&#xD;
             preceding screening visit.&#xD;
&#xD;
          2. Patients treated with hydroxycarbamide for any reason within the previous 6 months.&#xD;
&#xD;
          3. Patients who have had chronic blood transfusion or transfusion in the last 3 months.&#xD;
&#xD;
          4. Patients with a history of hypertension (systolic blood pressure ≥ 140 or diastolic&#xD;
             blood pressure ≥ 90 mmHg) treated with antihypertensive agent belonging to&#xD;
             pharmacological class of RAS inhibitor.&#xD;
&#xD;
          5. Patients who have symptoms suggestive of urinary tract infection or patients with&#xD;
             gross haematuria.&#xD;
&#xD;
          6. Patients with a concomitant primary kidney disease.&#xD;
&#xD;
          7. Patients with any systemic condition that could result in a glomerulopathy not related&#xD;
             to SCD (e.g. diabetes mellitus, active hepatitis B or C infections, HIV infection,&#xD;
             systemic lupus erythematosus, inflammatory arthropathies).&#xD;
&#xD;
          8. Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR &lt; 60 mL/min per 1.73 m2).&#xD;
&#xD;
          9. Patients with eGFR ≥ 140 ml/min/1,73m² due to the lack of information regarding the&#xD;
             magnitude, direction and significance of the trends in eGFR evolution that could be&#xD;
             expected in this population&#xD;
&#xD;
         10. Patients requiring long-term treatment with drugs potentially nephrotoxic (see&#xD;
             non-exhaustive list).&#xD;
&#xD;
         11. Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion&#xD;
             regardless of the indication.&#xD;
&#xD;
         12. Patients requiring long-term treatment with non-steroid anti-inflammatory drugs.&#xD;
&#xD;
         13. Patients who have a treatment which can modify the kidney function (see non-exhaustive&#xD;
             list) in the last 3 months.&#xD;
&#xD;
         14. Patients known to be infected with HIV.&#xD;
&#xD;
         15. Female patients who are pregnant or lactating.&#xD;
&#xD;
         16. Unreliable patients including non-compliant patients, patients with known alcoholism&#xD;
             or drug abuse or with a history of a serious psychiatric disorder as well as patients&#xD;
             unwilling to give informed consent or to abide by the requirements of the protocol.&#xD;
&#xD;
         17. Simultaneous participation in other clinical trials on an investigational medicinal&#xD;
             product or previous participation within 30 days before inclusion.&#xD;
&#xD;
         18. Persons in detention by judicial or administrative decision.&#xD;
&#xD;
         19. Patients with chronic conditions that upon investigator judgment may lead to a limited&#xD;
             life expectancy&#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>Pablo Bartolucci, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henri Mondor University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vincent Audard, Pr</last_name>
    <role>Study Chair</role>
    <affiliation>Henri Mondor University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Thomas-bourgneuf</last_name>
    <phone>+ 33 1 49 70 95 83</phone>
    <email>laura.thomas-bourgneuf@addmedica.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)</name>
      <address>
        <city>Abidjan</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aurelien Yapi, Dr</last_name>
    </contact>
    <investigator>
      <last_name>Aurélien Yapi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-André</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pablo Bartolucci</name>
      <address>
        <city>Créteil</city>
        <zip>94017</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pablo Bartolucci, Pr</last_name>
      <email>pablo.bartolucci@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Pablo Bartolucci, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanna Cannas</last_name>
      <email>giovanna.cannas@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Giovanna Cannas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Estelle Jean</last_name>
      <email>Estelle.JEAN@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>Estelle Jean</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanuelle Bernit</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital européen Georges-Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Benoît Arlet, Pr</last_name>
      <email>jean-benoit.arlet@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Benoît Arlet, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Service de biothérapie, consultation hématologie-drépanocytose hôpital Necker</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU la Miletrie</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justine Gellen-Dautremer</last_name>
      <email>justine.gellen-dautremer@chu-poitiers.fr</email>
    </contact>
    <investigator>
      <last_name>Justine Gellen-Dautremer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré CHU Reims</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stanislas Nimubona</last_name>
      <email>stanislas.nimubona@chu-rennes.fr</email>
    </contact>
    <investigator>
      <last_name>Stanislas Nimubona</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Delafontaine</name>
      <address>
        <city>Saint-Denis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer de Toulouse - Oncopole</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Pointe-à-Pitre/Abymes</name>
      <address>
        <city>Pointe-à-Pitre</city>
        <country>Guadeloupe</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maryse Etienne-Julan</last_name>
      <email>maryse.etienne-julan@chu-guadeloupe.fr</email>
    </contact>
    <investigator>
      <last_name>Maryse Etienne-Julan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD)</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aldiouma Guindo, Pr</last_name>
      <email>aldguindo@icermali.org</email>
    </contact>
    <investigator>
      <last_name>Aldiouma Guindo, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Martinique</name>
      <address>
        <city>Le Lamentin</city>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gylna Loko</last_name>
      <email>gylna.loko@chu-martinique.fr</email>
    </contact>
    <investigator>
      <last_name>Gylna Loko</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service d'Hématologie Clinique, Centre National de Transfusion sanguine, Université Cheikh Anta Diop</name>
      <address>
        <city>Dakar</city>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saliou Diop, Pr</last_name>
      <email>saliou.diop@ucad.edu.sn</email>
    </contact>
    <investigator>
      <last_name>Saliou Diop, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Côte D'Ivoire</country>
    <country>France</country>
    <country>Guadeloupe</country>
    <country>Mali</country>
    <country>Martinique</country>
    <country>Senegal</country>
  </location_countries>
  <removed_countries>
    <country>French Guiana</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>albuminuria</keyword>
  <keyword>hydroxycarbamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuminuria</mesh_term>
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxyurea</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03806452
org study id: SIK-FR-17-1
nct id: NCT03806452
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this phase IIb, international, multicentre, double-blind, randomised,
      placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after
      6 months of treatment in SCD adult patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of patients achieving at least a 30% decrease in ACR baseline value
time frame: 6 months
measure: Absolute mean changes in eGFR value
time frame: 6 months
measure: Absolute mean changes in ACR value
time frame: 6 months
measure: Proportion of patients with a shift from macroalbuminuria to microalbuminuria
time frame: 6 months
measure: Proportion of patients with a shift from microalbuminuria to normoalbuminuria
time frame: 6 months
measure: Proportion of patients with a shift from macroalbuminuria to normoalbuminuria
time frame: 6 months
measure: Proportion of patients with a shift from microalbuminuria to macroalbuminuria
time frame: 6 months
measure: Evolution curve of ACR
time frame: 6 months
measure: Evolution curve of ACR
time frame: From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.
measure: Evolution curve of eGFR
time frame: 6 months
measure: Evolution curve of eGFR
time frame: From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.
measure: Identification of clinical markers associated with response to treatment.
time frame: 6 months
description: Reported any sickle cell disease related organopathy
measure: Identification of biological markers associated with response to treatment.
time frame: 6 months
description: Haematology: Red blood cell count and Mean Corpuscular Volume, Dense Red Blood Cells, reticulocytes, Hemoglobin, free Hemoglobin and Fetal hemoglobin, Mean Corpuscular Hemoglobin and Mean Corpuscular Hemoglobin Concentration, hematocrit, White Blood Cell counts, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet counts, endogenous EPO and ferritin concentrations.
Blood biochemistry : Renal function: blood Creatinine. Haemolysis biochemical markers: Lactate Deshydrogenase, aspartate aminotransferase, ALT, BUN, conjugated and total bilirubin.
measure: Incidence of treatment-emergent AEs and SAEs
time frame: Through study completion
measure: Absolute mean changes of systolic blood pressure
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes of body mass index
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes of diastolic blood pressure
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes of heart rate measure
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in white blood cells count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in platelets count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in mean corpuscular volume
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in mean corpuscular haemoglobin concentration
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in mean corpuscular haemoglobin
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in hemoglobin count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in foetal hemoglobin count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in free hemoglobin count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in Dense red blood cells percentage
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in endogenous erythropoietin count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in ferritin count
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in lactate dehydrogenase
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in Aspartate aminotransferase
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in Alanine Amino Transferase
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in blood urea nitrogen
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in conjugated bilirubin
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in total bilirubin
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Absolute mean changes in reticulocytes
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Rate of SCD-related clinical events
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
measure: Biomarkers predictive of SCN (only French patients)
time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
arm group label: Hydroxycarbamide
arm group type: Experimental
description: Hydroxycarbamide will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Hydroxycarbamide will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.
Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Placebo will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.
Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.
intervention type: Drug
intervention name: Hydroxycarbamide
description: Hydroxycarbamide tablets of 100 and 1000 mg
arm group label: Hydroxycarbamide
other name: Siklos
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pablo Bartolucci, Pr
role: Principal Investigator
affiliation: Henri Mondor University Hospital
last name: Vincent Audard, Pr
role: Study Chair
affiliation: Henri Mondor University Hospital
last name: Laura Thomas-bourgneuf
phone: + 33 1 49 70 95 83
email: laura.thomas-bourgneuf@addmedica.com
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Côte D'Ivoire
country: France
country: Guadeloupe
country: Mali
country: Martinique
country: Senegal
country: French Guiana
responsible party type: Sponsor
mesh term: Albuminuria
mesh term: Anemia, Sickle Cell
mesh term: Hydroxyurea
sharing ipd: No