A clinical trial to study the effectiveness and safety of daily steroid plus cyclophosphamide versus alternate monthly steroid and cyclophosphamide in adults with membranous nephropathy with nephrotic syndrome
- Conditions
- Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
- Registration Number
- CTRI/2024/02/062982
- Lead Sponsor
- Department of Nephrology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age 18 to 80 years with nephrotic syndrome
2.Membranous nephropathy diagnosed by renal biopsy
3.Patients classified as moderate risk, high risk or very risk as defined by KDIGO 2021 guidelines for membranous nephropathy
4.Estimated GFR more than 30 ml/min/1.73m2 of body surface area, as calculated using CKD-EPI formula
5.In females, has to be practicing medically approved method of contraception, or surgically sterile or post-menopausal
1.Secondary causes of membranous nephropathy will be excluded (SLE, medications like NSAIDs, COX-2 inhibitors, malignancy)
2.Active underlying infection, including but not limited to hepatitis B, hepatitis C, HIV
3.Pregnant or breast-feeding women
4.Allergy or hypersensitivity to cyclophosphamide (oral or intravenous)
5.Immunosuppressant intake in the 6 months prior to enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the remission rate (complete or partial) at 6 months in patients treated with daily oral steroid plus cyclophosphamide versus cyclical steroid and cyclophosphamide therapyTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method 1.To compare proportion of patients with relapse in both treatment groups at 12 and 24 months. <br/ ><br>2.To compare renal survival (patients not having more than 50% decline from baseline eGFR or not developing ESRD) and patient survival in both groups at 12 and 24 months. <br/ ><br>3.To compare adverse events in both treatment groups. <br/ ><br>Timepoint: 6 months, 12 months and 24 months