PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 19:48:39 GMT)

CTRI Number CTRI/2018/01/011057 [Registered on: 01/01/2018] - Trial Registered Retrospectively Last Modified On 21/06/2021 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study "Treatment of membranous nephropathy with rituximab". Scientific Title of "Study comparing modified ponticelli regimen and rituximab in idiopathic membranous Study nephropathy". Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Abhinaba Debnath Trial Coordinator (multi-center study) Designation Postdoctoral trainee ( nephrology ) Affiliation IPGMER and SSKM hospital Address Dept of nephrology, 242 A J C bose road, IPGMER and SSKM hospital, 20 Room no 511, Doctors hostel [PG/SSKM hospital], 242 AJC bose road, Bhowanipore, Kolkata 20 Kolkata 700020 Phone 8797697255 Fax 00000000 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sanjay Dasgupta Query) Designation Associate Professor ( MD, DM ) - guide of the study Affiliation IPGMER and SSKM hospital, Kolkata Address Dept of nephrology, 242 A J C bose road, IPGMER and SSKM hospital, Kolkata 20 BF 51, sector 1, Salt lake, Kolkata 64 Kolkata WEST BENGAL 700020 India Phone 9830082267 Fax 00000000 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Abhinaba Debnath Designation Postdoctoral trainee ( nephrology ) Affiliation IPGMER and SSKM hospital Address Dept of nephrology, 242 A J C bose road, IPGMER and SSKM hospital, Kolkata 20 Room no 511, Doctors hostel [PG/SSKM hospital], 242 AJC bose road, Bhowanipore, Kolkata 20 Kolkata WEST BENGAL 700020 India

page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

Phone 8797697255 Fax 00000000 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > IPGMER and SSKM hospital, 242 AJC bose road, Bhowanipore, Kolkata - 20 [ All the tests done in this study and drugs given to patients are free of cost ( supplied by West Bengal govt. ) ] Primary Sponsor Primary Sponsor Details Name IPGMER and SSKM hospital Address 242 AJC bose road Bhowanipore Kolkata 20 West Bengal Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Abhinaba Debnath IPGMER and SSKM Dept. of nephrology, 8797697255 hospital 242 AJC bose road, Bhowanipore, Kolkata [email protected] 700020 om Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IPGMER Research Approved 27/03/2017 No Oversight Committee [ Institutional Ethics Committee] Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Idiopathic Membranous Nephropathy Patients Nephrotic syndrome with diffuse membranous glomerulonephritis Intervention / Type Name Details Comparator Agent Intervention Treatment of Idiopathic Patients will be treated with i v Membranous Nephropathy with rituximab or modified ponticelli immunosuppressant. regimen and response will be compared between 2 groups. Comparator Agent Cyclical Arm-I will receive Cyclical corticosteroid/alkylating-agent ( corticosteroid/alkylating-agent modified Ponticelli Regimen ), therapy for IMN [ the ‘‘Modified Rituximab. Ponticelli Regimen’’ - Month 1: i.v. methylprednisolone (1 g) daily for three doses, then oral methyl prednisolone (0.5 mg/kg/d) for 27 days; Month 2: oral cyclophosphamide (2.0 mg/kg/d) for 30 days; Month 3: Repeat Month 1; Month 4: Repeat Month 2; Month 5: Repeat Month 1; Month 6:

page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

Repeat Month 2 ]. Comparator Agent Cyclical Arm-II will receive injection corticosteroid/alkylating-agent ( rituximab 375 mg/m2 BSA once modified Ponticelli Regimen ), weekly intravenous for 4 dose. Rituximab. To reduce the infusion reaction 100 mg iv methyl prednisolone will be given prior to first dose of rituximab. Patient will be monitored for infusion related reaction and screened for infection. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details INCLUSION CRITERIA

1. Biopsy proven IMN, fulfilling the criteria for initiation of immunosuppression.
2. Estimated glomerular filtration rate (by MDRD) >30 ml/min/1.73m2 BSA.
3. Persistent proteinuria >4g/24 hr or > 50% of the baseline value despite receiving maximum tolerable dose of antiproteinuric medication (ACEI/ARBs/Statins ) for last 6 months.
4. Severe disabling or life threatening symptoms related to the nephrotic syndrome.
5. Conditions necessary for the use of immunosuppressant.
6. No contraindication to any of the medication used in the study.
Exclusion Criteria Exclusion Criteria Details EXCLUSION CRITERIA

1. Patients with active infection. 2. Diabetes mellitus. 3. Hepatitis B/C or human immunodeficiency virus infection. 4. Liver function abnormalities. 5. Neoplasia. 6. Chronic Diarrhoea. 7. Pregnancy. 8. Patients not willing for contraception. 9. Membranous lupus nephritis. 10. Previous therapy with Prednisolone, MMF, CSA within 4 months and alkylating agents within 6 months. 11. More than one episode of serious infections (e.g. peritonitis, lower respiratory infection, cellulitis) in the past 12 months, current or previous therapy for tuberculosis.

Method of Generating Random Number Table Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints The primary outcome will be the cumulative Final outcome will be assessed at month 12. number of patients who will experience remission both partial and complete remission on the basis of urine protein analysis. Secondary Outcome Outcome Timepoints The secondary outcome 15 months

page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

a) Estimated glomerular filtration rate (eGFR) at the completion of therapy b) Change in Sr albumin level c) Change in lipid profile d) Time required for complete or partial remission e) Adverse effects (Myelosuppression, hematuria, impaired glucose tolerance (IGT)/diabetes mellitus, diarrhoea and impaired fasting lipid profile, infection).

Target Sample Size Total Sample Size=20 Sample Size from India=20 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 15/03/2017 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details NA Brief Summary The only treatments of proven value in primary MGN involve alkylating agents (cyclophosphamide or chlorambucil) used over a period of 6 months. Published studies have always combined this with high-dose corticosteroid therapy. These treatments are toxic, so are reserved by most clinicians for patients who are deteriorating despite conservative measures after a period of observation and optimization of supportive management.

As the alternative medication has their own toxic effect we have to find other novel agent with good efficacy and better side effect profile. Rituximab (RTX), a chimeric monoclonal antibody directed against CD20-bearing cells, has emerged as an option in the treatment of primary MGN.

In this study we will compare the safety and efficacy of ‘‘modified ponticelli regimen’’, comprising cyclical corticosteroid/alkylating agent for 6 months with intravenous rituximab in the management of idiopathic membranous nephropathy.

The objectives of this study are:

1. Compare the efficacy of ‘‘modified ponticelli regimen’’ and rituximab in idiopathic membranous nephropathy.

2. Compare the percentage of change of proteinuria in response to “modified ponticelli regimen”

page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

and rituximab.

3. Compare the side effect profile and tolerability of ‘‘modified ponticelli regimen’’ and rituximab in idiopathic membranous nephropathy.

page 5 / 5

Powered by TCPDF (www.tcpdf.org)