]>
IRCT20230517058211N1 IRCT 2023-07-18 Jinnah Hospital/ Allama Iqbal Medical College Intravenous and oral cyclophosphamide in membranous nephropathy CIMNT (Cyclophosphamide in membranous nephropathy trial) Comparison of efficacy and safety of intravenous cyclophosphamide and steroids with oral cyclophosphamide and steroids in the treatment of idiopathic membranous nephropathy 2023-06-01 anticipated 58 Complete https://irct.ir/trial/70272 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned into two groups randomly by lottery method. Lottery method will be. Non probability / consecutive sampling technique will be used. The researcher randomly picks envelops for each with numbers, with each number corresponding to a subject in order to create the sample. To create a sample this way, the researcher must ensure that the numbers are well mixed before selecting the sample population. 3 Primary Membranous Nephropathy. 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 patient's cell count and C Reactive protein (CRP) will be checked. In months 1, 3 and 5 Injection Methypredisolone 1gram intravenously once a day for first 3 days, then Tab Prednisolone 0.5 mg/Kg body weight will be given in two divided doses for next 27 days.Total treatment wil be of six months. Intervention 2: Control group: Oral cyclophosphamide 2mg/kg in two divided doses on 2,4 and 6 months. Before cyclophosphamide treatment patient's cell count and C Reactive protein (CRP) will be checked. In months 1, 3 and 5 Injection Methypredisolone 1gram intravenously once a day for first 3 days, then Tab Prednisolone 0.5 mg/Kg body weight will be given in two divided doses for next 27 days. Total treatment wil be of six months. Yes - There is a plan to make this available What will be shared: Intravenous versus oral cyclophosphamide in Primary Membranous Nephropathy. Data will be availale in Excel sheets of all participants of study including their primary and secondary outcomes When: Data about the participants of both arms and their outcomes will be available Data will be available after May 2024 and it will be available 6 months after publication To whom: Only for doctors working in teaching institutes Conditions: Data can only be used by health professionals for research purposes Where to obtain: Data will be available through email: saleemdr5@gmail.com How to obtain: Person who needs data should ask for permission of usage of data through email provided. Email should include name, position held, teaching institute and purpose of using data. Comments: Our study data will be available for any ongoing study if needed
public Dr Muhammad Saleem
Jinnah Hospital , Allama Shabir Ahmad Usmani Road, Faisal Town
Lahore Pakistan 54550 +92 332 8376745 saleemdr5@gmail.com Jinnah Hospital/ Allama Iqbal Medical College scientific Dr Muhammad Saleem
Jinnah Hospital , Allama Shabir Ahmad Usmani Road, Faisal Town
Lahore Pakistan 54550 +92 332 8376745 saleemdr5@gmail.com Jinnah Hospital/ Allama Iqbal Medical College Pakistan 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). 18 years 80 years Both 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 N04.2 Nephrotic syndrome with diffuse membranous glomerulonephritis Treatment - Drugs Treatment - Drugs 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 patient's cell count and C Reactive protein (CRP) will be checked. In months 1, 3 and 5 Injection Methypredisolone 1gram intravenously once a day for first 3 days, then Tab Prednisolone 0.5 mg/Kg body weight will be given in two divided doses for next 27 days.Total treatment wil be of six months Control group: Oral cyclophosphamide 2mg/kg in two divided doses on 2,4 and 6 months. Before cyclophosphamide treatment patient's cell count and C Reactive protein (CRP) will be checked. In months 1, 3 and 5 Injection Methypredisolone 1gram intravenously once a day for first 3 days, then Tab Prednisolone 0.5 mg/Kg body weight will be given in two divided doses for next 27 days. Total treatment wil be of six months 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. 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. Jinnah Hospital/ Allama Iqbal Medical College Approved 2023-03-31 Ethical review board, Allama Iqbal Medical College/ Jinnah hospital, Lahore Allama Shabir Ahmad usmai Road, Lahore . Lahore Punjab Pakistan