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
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