Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

T

The University of The West Indies

Status

Unknown

Conditions

Sickle Cell Nephropathy
Microalbuminuria

Treatments

Drug: Enalapril
Drug: N-Acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT01891292
ECP 172, 10/11

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Control
No Intervention group
Enalapril
Active Comparator group
Treatment:
Drug: Enalapril
N-Acetylcysteine
Active Comparator group
Treatment:
Drug: N-Acetylcysteine

Trial contacts and locations

1

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Central trial contact

Lesley King, MB.BS

Data sourced from clinicaltrials.gov

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