Efficacy of Antioxidant Therapy Compared With Enalapril i... | NCT01891292

Studies
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

NCT01891292

Sponsor

The University of The West Indies

Status

Unknown status

Last Update Posted

Jul 3, 2013Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Microalbuminuria
Sickle Cell Nephropathy

Interventions

Enalapril
N-Acetylcysteine

Countries

Jamaica

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Name	Class
Caribbean Health Research Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Control	No Intervention
Enalapril	Active Comparator	Drug: Enalapril
N-Acetylcysteine	Active Comparator	Drug: N-Acetylcysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enalapril	Drug	0.25-0.35 mg/kg/day	Enalapril
N-Acetylcysteine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary albumin excretion rate		12 months

Secondary Outcomes

Measure	Description	Time Frame
Glomerular filtration rate	Measurement of glomerular filtration rate by iohexol	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lesley King, MB.BS	Contact	976-927-2471		lesley.king@uwimona.edu.jm

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sickle Cell Unit		Kingston			Jamaica

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34932828	Derived	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.

ID	Term
D004151	Dipeptides
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Term
D004656	Enalapril
D000111	Acetylcysteine