Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Microalbuminuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01891292
• Other study ID #: ECP 172, 10/11
• Status: Not yet recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: June 27, 2013
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: June 2013
• Source: The University of The West Indies
• Contact: Lesley King, MB.BS
• Phone: 976-927-2471
• Email: lesley.king[@]uwimona.edu.jm
• Is FDA regulated: No
• Health authority: Jamaica: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Microalbuminuria
• Sickle Cell Nephropathy

Intervention

Drug:
• Enalapril
0.25-0.35 mg/kg/day
• N-Acetylcysteine
N-Acetylcysteine 0.5 mmol/kg

Locations

Country	Name	City	State
Jamaica	Sickle Cell Unit	Kingston

Sponsors (2)

Lead Sponsor	Collaborator
The University of The West Indies	Caribbean Health Research Council

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary albumin excretion rate		12 months	No
Secondary	Glomerular filtration rate	Measurement of glomerular filtration rate by iohexol	12 months	No