Skip to content

Intravenous and oral cyclophosphamide in membranous nephropathy

Comparison of efficacy and safety of intravenous cyclophosphamide and steroids with oral cyclophosphamide and steroids in the treatment of idiopathic membranous nephropathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230517058211N1
Enrollment
58
Registered
2023-07-18
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Primary Membranous Nephropathy. Nephrotic syndrome with diffuse membranous glomerulonephritis

Interventions

Intervention 1: Intervention group: Intravenous cyclophosphamide 500mg/m2 on 2, 4 and 6 months. Injection Cyclophosphamide wil be given as infusion of 100 ml saline over 1 hour. Before infusion patien

Sponsors

Jinnah Hospital/ Allama Iqbal Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Serum Anti-Phospho Lipase A2 Receptor positive or IgG4 positivity on Immunofluorescence. Biopsy –proven Idiopathic Membranous Nephropathy, moderate risk group (Spot Urine protein/ spot urine creatinine Ratio between 4 to 8 g/g) that has failed to respond to conservative therapy for 6 months. Biopsy–proven Idiopathic Membtanous Nephropathy high risk group (Spot Urine protein/ spot urine creatinine Ratio more than 8g/g).

Exclusion criteria

Exclusion criteria: Patients with clinical, histologic, or serologic evidence of secondary Membranous Nephropathy. Evidence of Hepatitis B/C and Human Immunodeficiency Virus Evidence of malignancy (Prostate Specific Antigen, Mammogram, Chest x-ray.) Active or ongoing infection/ Recent infection. Allergy to cyclophosphamide. Contraindication to steroid/ cyclophosphamide

Design outcomes

Primary

MeasureTime frame
Reduction in proteinuria calculated by spot urine protein: creatinine ratio less than 0.2. Timepoint: Monthly for 6 months after starting treatment, then monthly follow up after 6 months of completion of treatment. Total 12 months. Method of measurement: Spot urine sample will be send to lab.

Secondary

MeasureTime frame
Hemoglobin. Timepoint: Monthly for 6 months after starting treatment (duration of treatment 6 months), then monthly follow up after 6 months of completion of treatment. Total 12 months. Method of measurement: Blood sample.;White cell count. Timepoint: Monthly for 6 months after starting treatment (duration of treatment 6 months), then monthly follow up after 6 months of completion of treatment. Total 12 months. Method of measurement: Blood sample.;Reduction in Serum Creatinine. Timepoint: Monthly for 6 months after starting treatment (duration of treatment 6 months), then monthly follow up after 6 months of completion of treatment. Total 12 months. Method of measurement: Blood sample.

Countries

Pakistan

Contacts

Public ContactDr Muhammad Saleem

Jinnah Hospital/ Allama Iqbal Medical College

saleemdr5@gmail.com+92 332 8376745

Outcome results

None listed

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