Trial | NCT01891292  Report issue

Title

Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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
Study Started
Jul 31
2013
Primary Completion
Aug 31
2014
Anticipated
Study Completion
Sep 30
2015
Anticipated
Last Update
Jul 03
2013
Estimate

Drug Enalapril

0.25-0.35 mg/kg/day

Drug N-Acetylcysteine

N-Acetylcysteine 0.5 mmol/kg

Control No Intervention

Enalapril Active Comparator

N-Acetylcysteine Active Comparator

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
No Results Posted