A study comparing rituximab with the usual steroid and cyclophosphamide treatment in adults with a kidney disease causing swelling and protein loss in urine, to find out which controls the disease better with fewer side effects

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Intervention arm: One group will be given inj rituximab 1gram IV ,2 doses with a gap of 2 weeks Non‐interventional arm: The other group will be given cyclical steroid and cyclophosphamide alternately (modified Ponticelli regimen) for si Xmonths‐ On Month 1,3,5‐ Injection Methylprednisolone 1000 mg will be given intravenously once daily for three days then followed by 0.5 mg/kg/day prednisolone for next 27 days. On Month 2,4,6 ‐ Tablet cyclophosphamide 2mg/kg/day will be given for 30 days : Intervention arm: One group will be given inj rituximab 1gram IV ,2 doses with a gap of 2 weeks Non‐interventional arm: The other group will be given cyclical steroid and cyclophosphamide alternately (modified Ponticelli regimen) for si Xmonths‐ On Month 1,3,5‐ Injection Methylprednisolone 1000 mg will be given intravenously once daily for three days then followed by 0.5 mg/kg/day prednisolone for next 27 days. On Month 2,4,6 ‐ Tablet cyclophosphamide 2mg/kg/day will be given for 30 days Intervention2: INJ RITUXIMAB: Rituximab 1 gram, intravenous infusion, given as 2 doses with a gap of 2 weeks between doses (i.e., on Day 1 and Day 15). Total duration of intervention: 2 weeks (2 doses). Control Intervention1: MODIFIED PONTICELLI REGIMEN: A 6‐month cyclical regimen of alternating corticosteroid and cyclophosphamide, administered as follows: Steroid months (Month 1, 3, 5): Injection Methylprednisolone 1000 mg, intravenous, once daily for 3 consecutive days, followed by Tablet Prednisolone 0.5 mg/kg/day, oral, once daily for the next 27 days. Cyclophosphamide months (Month 2, 4, 6): Tablet Cyclophosphamide 2 mg/kg/day, oral, once daily for 30 days. CONDITION: Health Condition 1: N042‐ Nephrotic syndrome with diffuse membranous glomerulonephritis PRIMARY OUTCOME: To compare the remission rate both compleet and partial, of Rituximab versus modified Ponticelli regimen in patients with primary membranous nephropathy. ; Timepoint: Baseline and at 1,2, 3, 4, 5, and 6 months of follow‐up, with the primary assessment at 6 months. SECONDARY OUTCOME: 1. To compare the adverse events , remission rates( complete or partial) , relapse rates of therapy in both treatment groups at 12months.Timepoint: 12 months INCLUSION CRITERIA: 1.Patients with age more than 18 years with nephrotic syndrome. 2.Biopsy confirmed cases of primary membranous nephropathy 3.Patients classified as moderate risk or high risk or very risk as defined by KDIGO 2021 guidelines for membranous nephropathy 4.Estimated GFR of more than 30 ml/min/1.73m2 of body surface area, as calculated using CKD‐ EPI formula. 6.In females, has to be practising medically approved method of contraception, or surgically sterile or post‐menopausal
Epistemonikos ID: 30a9ab6bfbcb4e8819be876e4db28f7dd2a71545
First added on: Oct 08, 2026