Study comparing two medications, namely injection rituximab and oral tablets of mycophenolate mofetil, in controlling the disease in patients with steroid resistant nephrotic syndrome who have had a relapsing illness during therapy with calcineurin inhibitors for more than two years

Phase 4

• Conditions: Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesionsHealth Condition 2: N040- Nephrotic syndrome with minor glomerular abnormality

• Registration Number: CTRI/2022/10/046890
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

(1) Age 5 - 18 years

(2) Idiopathic steroid resistant NS, initial or late resistance

(3) Minimal change disease or focal segmental glomerulosclerosis

(4) Therapy with either calcineurin inhibitor (CNI, cyclosporine or tacrolimus) for two years or longer

(5) Complete or partial remission during therapy with CNI

(6) Infrequent or frequent steroid sensitive relapses during therapy with CNI

Exclusion Criteria

(1) Nephrotic syndrome secondary to systemic disease or infection

(2) Therapy with rituximab or mycophenolate mofetil in the last two years

(3) Inability to swallow tablets or capsules of mycophenolate mofetil

(4) Chronic infection with hepatitis B or C or human immunodeficiency virus

(5) Impaired renal function, as indicated by eGFR <60 mL/min per 1.73 square meter

(6) Leukopenia, neutropenia, thrombocytopenia, elevated hepatic transaminases or hypogammaglobulinemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified