Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

June 27, 2013 updated by: Marvin Reid, The University of The West Indies

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston, Jamaica
        • Sickle Cell Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Enalapril
Drug: Enalapril
0.25-0.35 mg/kg/day
Active Comparator: N-Acetylcysteine
Drug: N-Acetylcysteine
N-Acetylcysteine 0.5 mmol/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary albumin excretion rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate
Time Frame: 12 months
Measurement of glomerular filtration rate by iohexol
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Collaborators

Caribbean Health Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP 172, 10/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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