NCT01891292

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 3, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

January 22, 2013

Last Update Submit

June 27, 2013

Conditions

MicroalbuminuriaSickle Cell Nephropathy

Outcome Measures

Primary Outcomes (1)

  • urinary albumin excretion rate

    12 months

Secondary Outcomes (1)

  • Glomerular filtration rate

    12 months

Study Arms (3)

Control

NO INTERVENTION

Enalapril

ACTIVE COMPARATOR
Drug: Enalapril

N-Acetylcysteine

ACTIVE COMPARATOR
Drug: N-Acetylcysteine

Interventions

EnalaprilDRUG

0.25-0.35 mg/kg/day

Enalapril
N-AcetylcysteineDRUG

N-Acetylcysteine 0.5 mmol/kg

N-Acetylcysteine

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Homozygous S sickle cell disease
  • Diagnosed by newborn screening
  • determined to have persistent microalbuminuria
  • satisfied criteria for microalbuminuria screening
  • parental consent

You may not qualify if:

  • Asymptomatic bacteriuria on screening urine cultures
  • On Hydroxyurea therapy
  • Pre-existing complications of SCD which would meet local criteria for HU therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sickle Cell Unit

Kingston, Jamaica

Location

Related Publications (1)

  • 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.

    PMID: 34932828DERIVED

MeSH Terms

Interventions

EnalaprilAcetylcysteine

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino Acids

Central Study Contacts

Lesley King, MB.BS

CONTACT

976-927-2471lesley.king@uwimona.edu.jm

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2013

First Posted

July 3, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2015

Last Updated

July 3, 2013

Record last verified: 2013-06

Locations

JA(1)