CompletedPhase 2

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

Côte d’Ivoire, France86 participantsStarted 2019-05-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value

Timeframe: 6 months

Trial details

NCT IDNCT03806452

SponsorTheravia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-30

Results submitted2025-04-07

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