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A study to compare two medicines, mycophenolate mofetil and tacrolimus, to see which one works better in helping children with kidney problems called nephrotic syndrome stay healthy and not get sick again too often

Mycophenolate mofetil versus tacrolimus for maintenance of remission in children with frequently relapsing and steroid dependent nephrotic syndrome: a randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058171
Enrollment
40
Registered
2023-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: N04- Nephrotic syndrome

Interventions

Intervention1: Mycophenolate mofetil: All new patients (2-18years) with FRNS/SDNS who will attend pediatric and nephrology OPD in presence of the principal investigator , after considering exclusion c

Sponsors

IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All new patients with primary FRNS/SDNS who will attend Nephrology and Pediatrics OPD

Exclusion criteria

Exclusion criteria: Patients who previously received any immunosuppressant other than corticosteroid Congenital nephrotic syndrome Secondary cause of nephrotic syndrome Children with Nephrotic syndrome who progressed to chronic kidney disease stage 3 or more Adequate required medical records not available Those who will be not willing to give consent/ assent

Design outcomes

Primary

MeasureTime frame
Proportion of the patients sustained remission in first 6 month following enrolment in the studyTimepoint: 6 month

Secondary

MeasureTime frame
Proportion of the patients sustained remission in next 6-12 months Outcome of kidney function Adverse events of the drugs used Incidence of hypertension Incidence of obesity Effect on growth of childTimepoint: 1year

Countries

India

Contacts

Public ContactMohsina Naj

Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

arunansu60@gmail.com7866851207

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026