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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)

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202201750782433
Enrollment
72
Registered
2022-01-21
Start date
2022-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatrics Kidney Disease

Interventions

Levamisole arm
Standard of care

Sponsors

The Molecular Pathology Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Number of Relapses in a period of 12 months post-randomization 2. Period of sustained remission within 12 months post-randomization.

Secondary

MeasureTime frame
1. Number of subjects in remission at 6, 12, and 18 months post-randomization 2. Number of solicited and unsolicited adverse events and serious events at 6, 12, and 18 months post-randomization

Countries

Nigeria

Contacts

Public ContactAdanze Asinobi

University College Hospital Ibadan

adasinobi@yahoo.com+2348038955880

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026