Status:
COMPLETED
Low Dose Iron Chelation as TReatment of Oxidative Damage in Sickle Cell Disease
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Objective: To study the safety and efficacy of deferasirox as treatment of oxidative stress in adult subjects with sickle cell disease. Endpoints: The investigators will determine whether treatment...
Detailed Description
Rationale: Sickle cell disease (SCD) is an inherited hemoglobinopathy, characterized by hemolysis, vaso-occlusive crises and organ damage resulting in reduced life expectancy. Oxidative stress is a m...
Eligibility Criteria
Inclusion
- Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- High performance liquid chromatography confirmed diagnosis of HbSS or HbSβ0 genotype.
- Aged 18-65 years
- Written informed consent
- Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Blood transfusion in the preceding four months
- Already using iron chelation due to iron overload
- Ferritin levels of \<50 µg/L and/or transferrin saturation of \< 0.20.
- LDH of \< 300 U/L
- Pregnancy or the desire to get pregnant in the following 6 months
- Impaired renal function of GFR \< 60 ml/min/1,73m2(CKD-EPI), or chronic medication that influences renal function
- Known allergic reaction to deferasirox.
- Other somatic or cognitive condition disturbing adherence to study treatment
Exclusion
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05392101
Start Date
July 20 2021
End Date
November 20 2022
Last Update
February 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdan UMC location AMC
Amsterdam, Meibergdreef 9, Netherlands, 1105 AZ