Trials / Completed
CompletedNCT03806452
SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)
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:
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Theravia · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxycarbamide | Hydroxycarbamide tablets of 100 and 1000 mg |
| DRUG | Placebo Oral Tablet | Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets |
Timeline
- Start date
- 2019-05-28
- Primary completion
- 2024-05-30
- Completion
- 2024-05-30
- First posted
- 2019-01-16
- Last updated
- 2025-05-14
- Results posted
- 2025-05-14
Locations
21 sites across 6 countries: Côte d’Ivoire, France, Guadeloupe, Mali, Martinique, Senegal
Source: ClinicalTrials.gov record NCT03806452. Inclusion in this directory is not an endorsement.