Efficacy And Safety of Levamisole in African Children With Nephrotic Syndrome: A Protocol For A Double-Blinded, Standard of Care-Controlled Randomized Trial (ESOLAC TRIAL)

Phase 4

• Conditions: Paediatrics; Kidney Disease

• Registration Number: PACTR202201750782433
• Lead Sponsor: The Molecular Pathology Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1.Children between the ages of 2 and 18 years as at the last birthday
2.Children with Steroid sensitive Nephrotic syndrome
3.Children with Idiopathic Nephrotic Syndrome
4.Children whose caregivers signed Informed consent for their participation in the study

Exclusion Criteria

1.Children with congenital anomaly of the urogenital system
2.Children with steroid-resistant nephrotic syndrome
3.Children who are receiving other immunosuppressive drugs
4.Children with End-Stage Renal Disease.
5.Children with Co-morbid conditions OR Systemic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of Relapses in a period of 12 months post-randomization <br>2. Period of sustained remission within 12 months post-randomization.<br>

Secondary Outcome Measures

Name	Time	Method
1. Number of subjects in remission at 6, 12, and 18 months post-randomization <br>2. Number of solicited and unsolicited adverse events and serious events at 6, 12, and 18 months post-randomization <br>