Status:
COMPLETED
SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)
Lead Sponsor:
Theravia
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03806452
Start Date
May 28 2019
End Date
May 30 2024
Last Update
May 14 2025
Active Locations (21)
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1
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
Abidjan, Côte d’Ivoire
2
CHU d'Angers
Angers, France
3
Hôpital Saint-André
Bordeaux, France
4
CHRU Brest
Brest, France