Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01891292

Enrollment

Registered

2013-07-03

Start date

2013-07-31

Completion date

2015-09-30

Last updated

2013-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microalbuminuria, Sickle Cell Nephropathy

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

Interventions

DRUGEnalapril

0.25-0.35 mg/kg/day

DRUGN-Acetylcysteine

N-Acetylcysteine 0.5 mmol/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
urinary albumin excretion rate	12 months

Secondary

Measure	Time frame	Description
Glomerular filtration rate	12 months	Measurement of glomerular filtration rate by iohexol

Countries

Jamaica

Contacts

Primary ContactLesley King, MB.BS

lesley.king@uwimona.edu.jm976-927-2471

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026