CTRI Trial Data

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

Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 03:07:02 GMT)

CTRI Number CTRI/2018/01/011316 [Registered on: 15/01/2018] - Trial Registered Retrospectively Last Modified On 11/01/2018 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Biological Study Design Randomized, Parallel Group Trial Public Title of Study A study compares the effectiveness and side effect of two drug named rituximab and tacrolimus in minimal change disease and Focal Segmental Glomerulosclerosis where steroid do not work Scientific Title of Open Label Randomized Control Trial Comparing Tacrolimus And Rituximab In Adult Onset Steroid Study Resistant Focal Segmental Glomerulosclerosis And Minimal Change Disease Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Rajib Mondal Trial Coordinator (multi-center study) Designation Post Doctoral trainee Affiliation IPGMER and SSKM Hospital Address Room no 249 Post Graduate Hostel IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata Department of Nephrology IPGMER and SSKM hospital bhowanipur 244, AJC Bose Road Kolkata-700020 Kolkata WEST BENGAL 700020 India Phone 9051076884 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Dipankar Sircar Query) Designation Associate Professor Affiliation IPGMER and SSKM hospital Address Department of Nephrology IPGMER and SSKM hospital Bhowanipur 244 AJC Bose road Kolkata 700020 Department of Nephrology IPGMER and SSKM hospital Bhowanipur 244 AJC Bose road Kolkata 700020 Kolkata WEST BENGAL 700020 India Phone 9433407355 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Rajib Mondal Designation Post Doctoral Trainee Affiliation IPGMER and SSKM hospital Address Room no 249 Post Graduate Hospital IPGMER and SSKM hospital 244 AJC Bose Road Kolkata Department of Nephrology IPGMER

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

and SSKM hospital bhowanipur 244 ajc bose road kolkata 700020 Kolkata WEST BENGAL 700020 India Phone 9051076884 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Institute of Post Graduate Medical Education and Research Seth Sukhlal Karnani Memorial Hospital Primary Sponsor Primary Sponsor Details Name Institute of Post Graduate Medical Education and Research Seth Sukhlal Karnani Memorial Hospital Address IPGMER and SSKM Hospital Bhowanipur 244 AJC Bose Road Kolhata 700020 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 Rajib Mondal IPGMER and SSKM IPGMER and SSKM 9051076884 hospital hospital 244 AJC Bose Road Bhowanipur rajibmondalmd@gmail. Kolkata 700020 com Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institute of Post Approved 07/03/2016 No Graduate Medical Education and Research Research Oversight Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients adult steroid resistant FSGS and MCD Intervention / Type Name Details Comparator Agent Intervention Tacrolimus Arm-I will receive tacrolimus at the dose of 0.075 mg/kg body weight. Dose adjusted to maintain tacrolimus trough level 5-10 ng/ml Comparator Agent Rituximab Arm-II will be received Injection rituximab 375 mg/m2 BSA once weekly intravenous for 4 dose Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s)

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

Age To 60.00 Year(s) Gender Both Details 1. Patient of age within 18-60 year.
2. Biopsy proven minimal change disease and focal segmental glomerulosclerosis
3. Receive 16 week of oral prednisolone in adequate dose without remission.
4. Estimated glomerular filtration (by MDRD) >30 ml/min/1.73m2 BSA
5. Tubular atrophy and fibrosis <25% of biopsy area.
6. Patient receiving maximum tolerable dose of antiproteinuric medication.
7. Patient willing to give consent for the study
8. No contraindication to any of the medication used in the study
Exclusion Criteria Exclusion Criteria Details 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. Secondary FSGS 9. Collapsing variant of FSGS 10. Previous therapy with MMF, azathioprine, cyclophosphamide and CSA 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 An Open list of random numbers Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints the cumulative number of patients who will 1 month 2 month 3 month 6 month 9 month and experience remission both partial and complete 12 month remission Secondary Outcome Outcome Timepoints a) Estimated glomerular filtration rate (eGFR) at 1year the completion of therapy b) Doubling of baseline serum creatinine levels (increase by 100%) c) Time will require for complete or partial remission d) Adverse effects (tremors, nephrotoxicity, gum hypertrophy, 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)=17 Final Enrollment numbers achieved (India)=17 Phase of Trial Phase 2 Date of First 10/03/2016 Enrollment (India) Date of First No Date Specified

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

Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details None Yet Brief Summary Focal segmental glomeruloselerosis (FSGS) and minimal change disease (MCD) are two most important cause of adult onset nephrotic syndrome. They can progress to ESRD. More the proteinuria more chance to progress to ESRD. In adult the remission rate is low than children and relapse rate is high. Nephrotic syndrome due to underlying minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) remains a therapeutic challenge for the treating physician. A high proportion of initial steroid responsive patients develop a steroid-dependent or steroid-resistant disease course necessitating the use of a high cumulative dose of steroids. As steroids per se exhibit an unfavourable spectrum of side effects, second or third-line immunosuppressive treatment options such as calcineurin inhibitors, mycophenolate mofetil, alkylating agents are often required in these patients to spare and reduce the side effects of steroid. There are, however, limitations to these alternative agents due to toxicity attributable to their use.

In steroid resistant MCD and FSGS the first line treatment is calcineurin inhibitor. Among them tacrolimus is a well-known entity. Tacrolimus is a macrolide immunosuppressant and calcineurin inhibitor that has immunosuppressant properties similar to cyclosporine and has a relatively selective inhibitory action on CD4 T-helper lymphocyte activation and proliferation. Tacrolimus has also antiproteinuric effect.

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

As the alternative medication has their own toxic effect researcher are finding other novel agent with good efficacy and better side effect profile. In the search some drug found which shows benefit in FSGS and MCD. Rituximab (RTX), a chimeric monoclonal antibody directed against CD20-bearing cells, has emerged as an option in the treatment of MCD or FSGS.

page 5 / 5