Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

NCT ID: NCT01891292

Last Updated: 2013-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Microalbuminuria Sickle Cell Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Enalapril

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

0.25-0.35 mg/kg/day

N-Acetylcysteine

Group Type ACTIVE_COMPARATOR

N-Acetylcysteine

Intervention Type DRUG

N-Acetylcysteine 0.5 mmol/kg

Interventions

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Enalapril

0.25-0.35 mg/kg/day

Intervention Type DRUG

N-Acetylcysteine

N-Acetylcysteine 0.5 mmol/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caribbean Health Research Council

OTHER

Sponsor Role collaborator

The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Marvin Reid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sickle Cell Unit

Kingston, , Jamaica

Site Status

Countries

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Jamaica

Central Contacts

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Lesley King, MB.BS

Role: CONTACT

976-927-2471

Facility Contacts

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Lesley King, MB.BS

Role: primary

8769272471

Marvin Reid, MB.BS

Role: backup

8769272471

References

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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.

Reference Type DERIVED
PMID: 34932828 (View on PubMed)

Other Identifiers

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ECP 172, 10/11

Identifier Type: -

Identifier Source: org_study_id

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