Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
Primary Purpose
Microalbuminuria, Sickle Cell Nephropathy
Status
Unknown status
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Enalapril
N-Acetylcysteine
Sponsored by
About this trial
This is an interventional prevention trial for Microalbuminuria
Eligibility 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
Sites / Locations
- Sickle Cell Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Enalapril
N-Acetylcysteine
Arm Description
Outcomes
Primary Outcome Measures
urinary albumin excretion rate
Secondary Outcome Measures
Glomerular filtration rate
Measurement of glomerular filtration rate by iohexol
Full Information
NCT ID
NCT01891292
First Posted
January 22, 2013
Last Updated
June 27, 2013
Sponsor
The University of The West Indies
Collaborators
Caribbean Health Research Council
1. Study Identification
Unique Protocol Identification Number
NCT01891292
Brief Title
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies
Collaborators
Caribbean Health Research Council
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microalbuminuria, Sickle Cell Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Enalapril
Arm Type
Active Comparator
Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
0.25-0.35 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
N-Acetylcysteine 0.5 mmol/kg
Primary Outcome Measure Information:
Title
urinary albumin excretion rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Glomerular filtration rate
Description
Measurement of glomerular filtration rate by iohexol
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lesley King, MB.BS
Phone
976-927-2471
Email
lesley.king@uwimona.edu.jm
Facility Information:
Facility Name
Sickle Cell Unit
City
Kingston
Country
Jamaica
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley King, MB.BS
Phone
8769272471
Email
lesley.king@uwimona.edu.jm
First Name & Middle Initial & Last Name & Degree
Marvin Reid, MB.BS
Phone
8769272471
Email
marvin.reid@uwimona.edu.jm
First Name & Middle Initial & Last Name & Degree
Lesley King, MB.BS
12. IPD Sharing Statement
Citations:
PubMed Identifier
34932828
Citation
Sasongko TH, Nagalla S. Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD009191. doi: 10.1002/14651858.CD009191.pub4.
Results Reference
derived
Learn more about this trial
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
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