Intravenous and oral cyclophosphamide in membranous nephropathy

Phase 3

Recruiting

Conditions: Primary Membranous Nephropathy.
Nephrotic syndrome with diffuse membranous glomerulonephritis
N04.2

Registration Number: IRCT20230517058211N1

Lead Sponsor: Jinnah Hospital/ Allama Iqbal Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 58

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.