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SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial) (SIKAMIC)

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hydroxycarbamide
Placebo Oral Tablet
Sponsored by
ADDMEDICA SASA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring albuminuria, hydroxycarbamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated Informed Consent Form (ICF) by a legally competent patient.
  2. Patients above 18 years.
  3. Patients with HbSS or HbSβ0 SCD.
  4. Patients with a value of albuminuria, assessed by ACR, over 3 mg/mmol and inferior to 100 mg/mmol confirmed by 3 positive urine samples taken one day apart.
  5. Female patients of childbearing potential or postmenopausal female with last period < 12 months before screening agreeing to use a highly effective form of contraception (oral, injected or implanted hormonal contraception, intrauterine device, diaphragm, condom) during the trial and for 3 months after hydroxycarbamide discontinuation.
  6. Male patients with partners of childbearing potential agreeing to use a highly effective contraception during the trial and for 3 months after hydroxycarbamide discontinuation. Men with pregnant or lactating women should be advised to use a barrier method of contraception (condom) to prevent the foetus or breastfed infant from exposure to hydroxycarbamide.
  7. Patients who are covered by insurance scheme according to local regulatory requierements.

Exclusion Criteria:

  1. Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks preceding screening visit.
  2. Patients treated with hydroxycarbamide for any reason within the previous 6 months.
  3. Patients who have had chronic blood transfusion or transfusion in the last 3 months.
  4. Patients with a history of hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 mmHg) treated with antihypertensive agent belonging to pharmacological class of RAS inhibitor.
  5. Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria.
  6. Patients with a concomitant primary kidney disease.
  7. Patients with any systemic condition that could result in a glomerulopathy not related to SCD (e.g. diabetes mellitus, active hepatitis B or C infections, HIV infection, systemic lupus erythematosus, inflammatory arthropathies).
  8. Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR < 60 mL/min per 1.73 m2).
  9. Patients with eGFR ≥ 140 ml/min/1,73m² due to the lack of information regarding the magnitude, direction and significance of the trends in eGFR evolution that could be expected in this population
  10. Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list).
  11. Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion regardless of the indication.
  12. Patients requiring long-term treatment with non-steroid anti-inflammatory drugs.
  13. Patients who have a treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months.
  14. Patients known to be infected with HIV.
  15. Female patients who are pregnant or lactating.
  16. Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol.
  17. Simultaneous participation in other clinical trials on an investigational medicinal product or previous participation within 30 days before inclusion.
  18. Persons in detention by judicial or administrative decision.
  19. Patients with chronic conditions that upon investigator judgment may lead to a limited life expectancy

Sites / Locations

  • Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
  • CHU d'Angers
  • Hôpital Saint-André
  • CHRU Brest
  • Hôpital Louis Mourier
  • Pablo BartolucciRecruiting
  • Hopital Edouard HerriotRecruiting
  • Hôpital de la TimoneRecruiting
  • Hôpital européen Georges-PompidouRecruiting
  • Hôpital Saint-Antoine
  • Service de biothérapie, consultation hématologie-drépanocytose hôpital Necker
  • CHU la MiletrieRecruiting
  • Hôpital Robert Debré CHU Reims
  • Hopital PontchaillouRecruiting
  • CHU Charles Nicolle
  • Centre Hospitalier Delafontaine
  • Institut Universitaire du Cancer de Toulouse - Oncopole
  • CHU Pointe-à-Pitre/AbymesRecruiting
  • Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD)Recruiting
  • CHU MartiniqueRecruiting
  • Service d'Hématologie Clinique, Centre National de Transfusion sanguine, Université Cheikh Anta DiopRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxycarbamide

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients achieving at least a 30% decrease in ACR baseline value

Secondary Outcome Measures

Absolute mean changes in eGFR value
Absolute mean changes in ACR value
Proportion of patients with a shift from macroalbuminuria to microalbuminuria
Proportion of patients with a shift from microalbuminuria to normoalbuminuria
Proportion of patients with a shift from macroalbuminuria to normoalbuminuria
Proportion of patients with a shift from microalbuminuria to macroalbuminuria
Evolution curve of ACR
Evolution curve of ACR
Evolution curve of eGFR
Evolution curve of eGFR
Identification of clinical markers associated with response to treatment.
Reported any sickle cell disease related organopathy
Identification of biological markers associated with response to treatment.
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.
Incidence of treatment-emergent AEs and SAEs
Absolute mean changes of systolic blood pressure
Absolute mean changes of body mass index
Absolute mean changes of diastolic blood pressure
Absolute mean changes of heart rate measure
Absolute mean changes in white blood cells count
Absolute mean changes in platelets count
Absolute mean changes in mean corpuscular volume
Absolute mean changes in mean corpuscular haemoglobin concentration
Absolute mean changes in mean corpuscular haemoglobin
Absolute mean changes in hemoglobin count
Absolute mean changes in foetal hemoglobin count
Absolute mean changes in free hemoglobin count
Absolute mean changes in Dense red blood cells percentage
Absolute mean changes in endogenous erythropoietin count
Absolute mean changes in ferritin count
Absolute mean changes in lactate dehydrogenase
Absolute mean changes in Aspartate aminotransferase
Absolute mean changes in Alanine Amino Transferase
Absolute mean changes in blood urea nitrogen
Absolute mean changes in conjugated bilirubin
Absolute mean changes in total bilirubin
Absolute mean changes in reticulocytes
Rate of SCD-related clinical events
Biomarkers predictive of SCN (only French patients)

Full Information

First Posted
January 9, 2019
Last Updated
June 14, 2023
Sponsor
ADDMEDICA SASA
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1. Study Identification

Unique Protocol Identification Number
NCT03806452
Brief Title
SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)
Acronym
SIKAMIC
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:
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADDMEDICA SASA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
albuminuria, hydroxycarbamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxycarbamide
Arm Type
Experimental
Arm 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 Title
Placebo
Arm Type
Placebo Comparator
Arm 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(s)
Hydroxycarbamide
Other Intervention Name(s)
Siklos
Intervention Description
Hydroxycarbamide tablets of 100 and 1000 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets
Primary Outcome Measure Information:
Title
Proportion of patients achieving at least a 30% decrease in ACR baseline value
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Absolute mean changes in eGFR value
Time Frame
6 months
Title
Absolute mean changes in ACR value
Time Frame
6 months
Title
Proportion of patients with a shift from macroalbuminuria to microalbuminuria
Time Frame
6 months
Title
Proportion of patients with a shift from microalbuminuria to normoalbuminuria
Time Frame
6 months
Title
Proportion of patients with a shift from macroalbuminuria to normoalbuminuria
Time Frame
6 months
Title
Proportion of patients with a shift from microalbuminuria to macroalbuminuria
Time Frame
6 months
Title
Evolution curve of ACR
Time Frame
6 months
Title
Evolution curve of ACR
Time Frame
From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.
Title
Evolution curve of eGFR
Time Frame
6 months
Title
Evolution curve of eGFR
Time Frame
From treatment initiation to month 12, for responder patients willing to continue the study after 6 months.
Title
Identification of clinical markers associated with response to treatment.
Description
Reported any sickle cell disease related organopathy
Time Frame
6 months
Title
Identification of biological markers associated with response to treatment.
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.
Time Frame
6 months
Title
Incidence of treatment-emergent AEs and SAEs
Time Frame
Through study completion
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Absolute mean changes in platelets count
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
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.
Title
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.
Title
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.
Title
Absolute mean changes in hemoglobin count
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Absolute mean changes in ferritin count
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
Absolute mean changes in lactate dehydrogenase
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
Absolute mean changes in Aspartate aminotransferase
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
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.
Title
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.
Title
Absolute mean changes in conjugated bilirubin
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
Absolute mean changes in total bilirubin
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
Absolute mean changes in reticulocytes
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
Rate of SCD-related clinical events
Time Frame
6 months and 12 months for responder patients willing to continue the study after month 6.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated Informed Consent Form (ICF) by a legally competent patient. Patients above 18 years. Patients with HbSS or HbSβ0 SCD. Patients with a value of albuminuria, assessed by ACR, over 3 mg/mmol and inferior to 100 mg/mmol confirmed by 3 positive urine samples taken one day apart. Female patients of childbearing potential or postmenopausal female with last period < 12 months before screening agreeing to use a highly effective form of contraception (oral, injected or implanted hormonal contraception, intrauterine device, diaphragm, condom) during the trial and for 3 months after hydroxycarbamide discontinuation. Male patients with partners of childbearing potential agreeing to use a highly effective contraception during the trial and for 3 months after hydroxycarbamide discontinuation. Men with pregnant or lactating women should be advised to use a barrier method of contraception (condom) to prevent the foetus or breastfed infant from exposure to hydroxycarbamide. Patients who are covered by insurance scheme according to local regulatory requierements. Exclusion Criteria: Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks preceding screening visit. Patients treated with hydroxycarbamide for any reason within the previous 6 months. Patients who have had chronic blood transfusion or transfusion in the last 3 months. Patients with a history of hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 mmHg) treated with antihypertensive agent belonging to pharmacological class of RAS inhibitor. Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria. Patients with a concomitant primary kidney disease. Patients with any systemic condition that could result in a glomerulopathy not related to SCD (e.g. diabetes mellitus, active hepatitis B or C infections, HIV infection, systemic lupus erythematosus, inflammatory arthropathies). Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR < 60 mL/min per 1.73 m2). Patients with eGFR ≥ 140 ml/min/1,73m² due to the lack of information regarding the magnitude, direction and significance of the trends in eGFR evolution that could be expected in this population Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list). Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion regardless of the indication. Patients requiring long-term treatment with non-steroid anti-inflammatory drugs. Patients who have a treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months. Patients known to be infected with HIV. Female patients who are pregnant or lactating. Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol. Simultaneous participation in other clinical trials on an investigational medicinal product or previous participation within 30 days before inclusion. Persons in detention by judicial or administrative decision. Patients with chronic conditions that upon investigator judgment may lead to a limited life expectancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Thomas-bourgneuf
Phone
+ 33 1 49 70 95 83
Email
laura.thomas-bourgneuf@addmedica.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Bartolucci, Pr
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Audard, Pr
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
City
Abidjan
Country
Côte D'Ivoire
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien Yapi, Dr
First Name & Middle Initial & Last Name & Degree
Aurélien Yapi, Dr
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Saint-André
City
Bordeaux
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU Brest
City
Brest
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Louis Mourier
City
Colombes
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pablo Bartolucci
City
Créteil
ZIP/Postal Code
94017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Bartolucci, Pr
Email
pablo.bartolucci@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pablo Bartolucci, Pr
Facility Name
Hopital Edouard Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Cannas
Email
giovanna.cannas@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Giovanna Cannas
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Jean
Email
Estelle.JEAN@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Estelle Jean
First Name & Middle Initial & Last Name & Degree
Emmanuelle Bernit
Facility Name
Hôpital européen Georges-Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Benoît Arlet, Pr
Email
jean-benoit.arlet@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Benoît Arlet, Pr
Facility Name
Hôpital Saint-Antoine
City
Paris
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Service de biothérapie, consultation hématologie-drépanocytose hôpital Necker
City
Paris
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU la Miletrie
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Gellen-Dautremer
Email
justine.gellen-dautremer@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Justine Gellen-Dautremer
Facility Name
Hôpital Robert Debré CHU Reims
City
Reims
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislas Nimubona
Email
stanislas.nimubona@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Stanislas Nimubona
Facility Name
CHU Charles Nicolle
City
Rouen
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Delafontaine
City
Saint-Denis
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Pointe-à-Pitre/Abymes
City
Pointe-à-Pitre
Country
Guadeloupe
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryse Etienne-Julan
Email
maryse.etienne-julan@chu-guadeloupe.fr
First Name & Middle Initial & Last Name & Degree
Maryse Etienne-Julan
Facility Name
Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD)
City
Bamako
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldiouma Guindo, Pr
Email
aldguindo@icermali.org
First Name & Middle Initial & Last Name & Degree
Aldiouma Guindo, Pr
Facility Name
CHU Martinique
City
Le Lamentin
Country
Martinique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gylna Loko
Email
gylna.loko@chu-martinique.fr
First Name & Middle Initial & Last Name & Degree
Gylna Loko
Facility Name
Service d'Hématologie Clinique, Centre National de Transfusion sanguine, Université Cheikh Anta Diop
City
Dakar
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saliou Diop, Pr
Email
saliou.diop@ucad.edu.sn
First Name & Middle Initial & Last Name & Degree
Saliou Diop, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

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SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

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