Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

• Sponsor: The University of The West Indies (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01891292
• Collaborator: Caribbean Health Research Council (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 26
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Microalbuminuria; Sickle Cell Nephropathy	Drug: Enalapril; Drug: N-Acetylcysteine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2014
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. urinary albumin excretion rate [12 months]

Secondary Outcome Measures

1. Glomerular filtration rate [12 months]

   Measurement of glomerular filtration rate by iohexol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sickle Cell Unit	Kingston		Jamaica

Sponsors and Collaborators

• The University of The West Indies
• Caribbean Health Research Council

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marvin Reid, Professor, The University of The West Indies
• ClinicalTrials.gov Identifier: NCT01891292
• Other Study ID Numbers: ECP 172, 10/11
• First Posted: Jul 3, 2013
• Last Update Posted: Jul 3, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Kidney Diseases; Acetylcysteine; Enalapril; N-monoacetylcystine

Study Results

No Results Posted as of Jul 3, 2013