Overview

Angiotensin-converting Enzyme Inhibitors and Early Sickle Cell Renal Disease in Children

Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years). Physiopathology of renal scarring is not well understood actually. Renal scarring might be due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26 sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six months treatment. It might be interesting studying ACE efficacy in sickle cell children with microalbuminuria because renal disease is directly related to sickle cell and is not influenced by other cardiovascular risk factors like in adult patients. We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine months treatment period. A success is defined as a 50% reduction of the albuminuria/creatinuria ratio.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Angiotensin-Converting Enzyme Inhibitors
Enalapril
Enalaprilat
Enzyme Inhibitors
Criteria
Inclusion Criteria:

- Sickle cell disease (SS, SC, Sb thalassemia, SD Punjab)

- Affiliation to French Health benefits

- Signed informed consent

- Albuminemia / Creatinemia >= 3 mg / mmol (on 2 samples)

Exclusion Criteria:

- Albuminemia / Creatinemia > 100 mg / mmol

- Hypersensibility to enalapril

- Angio-oedemas due to a previous treatment by ACE

- idiopathic or hereditary angio-oedemas

- cerebral echo-doppler

- treatment by lithium digoxine

- treatment by other ACE

- congenital galactosemia

- Pregnancy