Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

The University of The West Indies30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Microalbuminuria Sickle Cell Nephropathy

Interventions

EnalaprilDRUG

0.25-0.35 mg/kg/day

N-AcetylcysteineDRUG

N-Acetylcysteine 0.5 mmol/kg

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sickle Cell Unit

Kingston, Jamaica

Outcomes

Primary Outcomes

urinary albumin excretion rate

Time frame: 12 months

Secondary Outcomes

Glomerular filtration rate

Measurement of glomerular filtration rate by iohexol

Time frame: 12 months

Central Contacts

Lesley King, MB.BS

CONTACT

976-927-2471 lesley.king@uwimona.edu.jm

Data from ClinicalTrials.gov

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