Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Not Applicable

• Conditions: Microalbuminuria; Sickle Cell Nephropathy
• Interventions: Drug: N-Acetylcysteine; Drug: Enalapril

• Registration Number: NCT01891292
• Lead Sponsor: The University of The West Indies

Brief Summary

The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-22
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study Start: 2013-07
• Study First Posted: 2013-07-03
• Last Update Posted: 2013-07-03
• Primary Completion: 2014-08
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Homozygous S sickle cell disease
• Diagnosed by newborn screening
• determined to have persistent microalbuminuria
• satisfied criteria for microalbuminuria screening
• parental consent

Exclusion Criteria

• Asymptomatic bacteriuria on screening urine cultures
• On Hydroxyurea therapy
• Pre-existing complications of SCD which would meet local criteria for HU therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-Acetylcysteine	N-Acetylcysteine	-
Enalapril	Enalapril	-

Primary Outcome Measures

Name	Time	Method
urinary albumin excretion rate	12 months

Secondary Outcome Measures

Name	Time	Method
Glomerular filtration rate	12 months	Measurement of glomerular filtration rate by iohexol

Trial Locations

Locations (1)

Sickle Cell Unit; 🇯🇲 Kingston, Jamaica