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

Efficacy and safety of daily oral steroid and cyclophosphamide versus cyclical steroid and cyclophosphamide in adult nephrotic syndrome patients with membranous nephropathy :A Randomized Controlled Trial. - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062982

Enrollment

180

Registered

2024-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis

Interventions

Intervention1: prednisolone and cyclophosphamide: Oral prednisolone (0.5 mg/kg/day)for three months followed by tapering over next three months by 5 mg every two weeks (total steroid duration-6months

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1.To compare proportion of patients with relapse in both treatment groups at 12 and 24 months. 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. 3.To compare adverse events in both treatment groups. Timepoint: 6 months, 12 months and 24 months	—

Countries

India

Contacts

Public ContactDr Paromita Das

All India Institute of Medical sciences, Bhubaneswar

nephro_sandip@aiimsbhubaneswar.edu.in9626801175

Outcome results

None listed

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