MedPath

Study comparing the ability of two medications, namely oral tablets of mycophenolate mofetil and cyclophosphamide, in keeping disease well controlled in patients with frequently relapsing or steroid dependent nephrotic syndrome

Phase 4
Conditions
Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
Registration Number
CTRI/2022/10/046891
Lead Sponsor
AIIMS New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients with idiopathic steroid sensitive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 12-months and with parents willing to give informed written consent and child giving informed written assent

Exclusion Criteria

Known secondary etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis)

Initial or late steroid resistance, currently or historically

Therapy with oral or intravenous cyclophosphamide or MMF ever in the past

Therapy with cyclosporine, tacrolimus, azathioprine or rituximab in the past 6 months

Inability to swallow tablets or capsules of MMF

Impaired renal function, as indicated by eGFR <60 mL/min per 1.73 m²

Leukopenia, neutropenia, thrombocytopenia, elevated transaminases

Known chronic infection (tuberculosis, HIV, hepatitis B or C) or malignancy

Residing more than 100 km away or unwilling to come for regular follow-up

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath