Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy

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