PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 10:03:34 GMT) CTRI Number CTRI/2017/12/010965 [Registered on: 22/12/2017] - Trial Registered Retrospectively Last Modified On 18/12/2017 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study Tacrolimus in adult onset minimal change disease Scientific Title of Long term outcome and side effect profiles of treating adult onset minimal change disease with Study tacrolimus versus steroid as the first line agent Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Malagouda R Patil Trial Coordinator (multi-center study) Designation Senior Resident Affiliation IPGMER and SSKM Hospital,kolkata. Dept. of Nephrology. Address Dept. of Nephrology, resident room, 5th floor, Nephrology building, IPGMER and SSKM Hospital,kolkata. Kolkata WEST BENGAL 700020 India Phone 8820283322 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Malagouda R Patil Query) Designation Senior Resident(Student) Affiliation IPGMER and SSKM Hospital,kolkata Address Dept. of Nephrology, Resident room, 5th floor, Nephrology building. IPGMER and SSKM Hospital,kolkata Kolkata WEST BENGAL 700020 India Phone 8820283322 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dipankar Sircar Designation Assistant Professor(Guide) Affiliation IPGMER and SSKM Hospital,kolkata Address Dept. of Nephrology, staff room, 5th floor, Nephrology building, IPGMER and SSKM Hospital,kolkata Kolkata WEST BENGAL 700020 India Phone page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dept. of Nephrology, Resident room, 5th floor, Nephrology building, IPGMER and SSKM Hospital kolkata. Primary Sponsor Primary Sponsor Details Name IPGMER and SSKM Hospital kolkata Address IPGMER and SSKM Hospital, AJC Bose road, kolkata 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 Malagouda R Patil IPGMER and SSKM Dept. of Nephrology, 8820283322 Hospital,kolkata Resident room, 5th floor, Nephrology [email protected] building. Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IPGMER Research Approved 25/03/2014 No Oversight Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Adult onset nephrotic syndrome. Intervention / Type Name Details Comparator Agent Comparator Agent Prednisolone Prednisolone is a oral steroid which is the drug of choice for treatment of adult MCD. Steroids have been the cornerstone of first line therapy in adult MCD patients. Response is often delayed in comparison with children, and 25% fail to remit after 3 to 4 months. Intervention Tacrolimus Tacrolimus is an immunosuppressive macrolide of the calcineurin inhibitor group that is widely used following organ transplantation. Tacrolimus is already known to be effective in treating patients with steroid-dependent and steroid-resistant nephrotic syndrome and can control the proteinuria associated with MCD due to its potent page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in immunosuppressive effect and its suppression of vascular permeability factor production. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 90.00 Year(s) Gender Both Details All patients aged over 18 years with biopsy-proven MCD with an Immunofluorescence staining negative for all stains and presence of nephrotic range proteinuria (>3.5gms/24hours) will be taken for study.<br/> Exclusion Criteria Exclusion Criteria Details The patients with any other glomerular or tubulo-interstitial pathology in the biopsy (including any overlap syndrome or variants of MCD), chronicity features on histopathology (interstitial fibrosis and tubular atrophy >20%), presence of active infection and prior exposure to any immunosuppressive agents for the same disease were excluded from the study. Patients with systemic diseases like SLE, diagnosed lymphoma/leukemia or suspicion of drug induced MCD were excluded. Method of Generating Random Number Table Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Complete remission, partial remission in each 6 months 12 months, 18 months groups, tacrolimus and steroid resistance measured at 12 and 18 months in steroid and tacrolimus groups. Secondary Outcome Outcome Timepoints Relapses, sustained remission, complications of 6 months, 12 months, 18 months therapy, drug dependency measured at 18 months. Target Sample Size Total Sample Size=48 Sample Size from India=48 Final Enrollment numbers achieved (Total)=48 Final Enrollment numbers achieved (India)=48 Phase of Trial N/A Date of First 01/04/2014 Enrollment (India) Date of First No Date Specified 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 NO Brief Summary Summary of results: page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in The baseline characteristics in the Tacrolimus and steroid group were similar except the diastolic blood pressure which was higher in the steroid group. Complete remission, partial remission, time to complete remission and time to partial remission was not statistically different in the two groups at 6 months. The number of relapses was numerically higher inTacrolimus group than steroid group but it did not reach statistical significance. page 4 / 4 Powered by TCPDF (www.tcpdf.org).