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Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

Information source: The University of The West Indies
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Microalbuminuria; Sickle Cell Nephropathy

Intervention: Enalapril (Drug); N-Acetylcysteine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: The University of The West Indies

Overall contact:
Lesley King, MB.BS, Phone: 976-927-2471, Email: lesley.king@uwimona.edu.jm

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

Clinical Details

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

Primary outcome: urinary albumin excretion rate

Secondary outcome: Glomerular filtration rate

Eligibility

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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 and Contacts

Lesley King, MB.BS, Phone: 976-927-2471, Email: lesley.king@uwimona.edu.jm

Sickle Cell Unit, Kingston, Jamaica; Not yet recruiting
Lesley King, MB.BS, Phone: 8769272471, Email: lesley.king@uwimona.edu.jm
Marvin Reid, MB.BS, Phone: 8769272471, Email: marvin.reid@uwimona.edu.jm
Lesley King, MB.BS, Sub-Investigator
Additional Information

Starting date: July 2013
Last updated: June 27, 2013

Page last updated: August 23, 2015

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