Clinical Trial Details (PDF Generation Date :- Sat, 05 May 2018 05:20:32 GMT) CTRI Number Last Modified On 06/04/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/002361 [Registered on: 23/01/2012] - Trial Registered Prospectively No Interventional Drug Single Arm Trial A clinical trial to study the safety and efficacy of once daily Advagraf in patients who are undergoing kidney or liver transplantation. An open label, multi-centre, prospective study to demonstrate safety and efficacy of once daily Advagraf in patients undergoing kidney or liver transplantation in India. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) AS/111/10/Version 3/1-Aug-2011 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr Pratik Shah Head- Clinical Research & Development Phone 912261557605 Fax 912261557699 Email Designation Affiliation 301, 3rd Floor, C and B Square, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai 400 059 NA Mumbai (Suburban) 400059 India pratik.shah@astellas.com Details Contact Person (Public Query) Dr Pratik Shah Head- Clinical Research & Development 301, 3rd Floor, C and B Square, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai 400 059 NA 400059 India Phone 912261557605 Fax 912261557699 page 1 / 7
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Email > Astellas Pharma India Pvt Limited. pratik.shah@astellas.com Source of Monetary or Material Support Primary Sponsor Details Astellas Pharma India Pvt. Ltd., 301, 3rd Floor, C and B Square, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai 400 059 Type of Sponsor List of Countries India of Principal Investigator Dr Anand Khakhar Dr Subba Rao Budithi Pharmaceutical industry-global Astellas Pharma India Pvt. Ltd., 301, 3rd Floor, C and B Square, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai 400 059 of Site Site Phone/Fax/Email Apollo Hospital Consultant Transplant 9952099499 and Hepatobiliary-Panc reatic Surgeon, anandkhakhar@gmail.c Hepatobi om liary-pancreatic Surgery,21 Greams Lane, Off Greams road, : 600006 Apollo Hospital Senior Consultant, 9840028640 Nephrology,21 Greams subbaraobudithi@hotm Lane, Off Greams road, ail.com : 600006 Dr Vikranht Reddy Care Hospital Consultant Nephrologist, Nephrology,Banjara Hills, Hyderabad: 500034 Hyderabad ANDHRA PRADESH Dr V Tamilarasi Dr M Rela Chritian Medical College Global Hospitals and Health City Head department of Nephrology, Nephrology,Christian Medical College Vellore: 632004 Vellore Consultant Liver transplant and Hepatobiliary surgery, Hepatobiliary Surgery,439; Cheran Nagar; Perumbakkam; 9849122585 vikranthreddy@yahoo.c om 9443007358 v.tamilarasi@hotmail.co m 9940534567 drmohamedrela@global hospitals.com page 2 / 7
Details of Ethics Committee Dr Subhash Gupta Dr M M Bahadur Dr Georgi Abraham Dr Alan Almeida Indraprastha Apollo Hospital Jaslok Hospital and Research Centre Madras Medical Mission P.D Hinduja National Hospital and Medical Research Centre 600100; Tamil Nadu, Senior consultant Liver transplant and Gastrosurgery, Transplant and Gastrosurgery, Sarita Vihar, Delhi Mathura Road, New Delhi: 110076 New Delhi DELHI Consultant, Nephrologis t. NEphrology,15, Dr. G Deshmukh Marg, Mumbai: 400026 Mumbai 9811075683 guptasubash@hotmail. com 9820183965 akdktr@jaslokhospital.n et Consultant Nephrologist 984142092, Nephrology,No 4-A, Dr. georgi_abraham@yaho J.J Nagar, Mogappair, o.com 600037, India Senior Consultant Nephrologist, Nephrology, Veer Savarkar Marg, Mahim, Mumbai: 400016 Mumbai Dr R K Sharma SGPGI Nephrology Head, Nephrology,Raebareli Road, Luckhnow: 226014 Gurgaon HARYANA Dr Dinesh Khullar Sir Gangaram Hospital Senior Consultant Nephrologist, Nephrology,Sir Gangaram Hospital Marg, Rajinder nagar, New Delhi: 100060 New Delhi DELHI 9322879750 almeidaa@gmail.com 9416026762 rksharma@sgpgi.ac.in 9810124066 dineshkhullar@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Care Foundation, Committee. Approved 12/01/2012 No page 3 / 7
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Christian Medical College, Institutional Review Board. Clinical Research and Ethics Committee,Hinduja Hospital Ethics Committee on Clinical Trials, Indraprastha Apollo Hospital Ethics Committee, Apollo Hospital Ethics Committee, Jaslok Hospital Ethics Committee, Sir Ganga Ram Hospital Ethics Committee,Apollo Hospitals Commitee, Columbia Asia Hospitals Committee, Global Hospitals Committee, Madras Medical Mission Committee, SGPGI Medanta Independent Ethics Committee Status Approved 10/01/2012 No Approved 29/03/2012 No Approved 29/06/2012 No Approved 14/12/2011 No Approved 20/12/2011 No Approved 21/03/2012 No Approved 09/11/2011 No Approved 29/11/2012 No Approved 26/05/2012 No Approved 28/12/2011 No Approved 05/01/2012 No Approved 26/11/2012 Yes Date Approved/Obtained 26/12/2011 Health Type Patients Condition study to demonstrate safety and efficacy of once daily Advagraf in patients undergoing kidney or liver transplantation in India Type Details Intervention ADVAGRAF The trial Involves use of Once Daily Modified Release ADVAGRAF ( Tacrolimus )0.5 mg, 1.0 mg, 5mg orally for twelve weeks. An immunosuppressant to demonstrate the safety and efficacy in patients undergoing kidney or liver transplantation in India. Comparator Agent NA NA Age From Age To 18.00 Year(s) 65.00 Year(s) Inclusion Criteria page 4 / 7
Gender Details Both Inclusion criteria Inclusion criteria (common to kidney and liver transplant patients) Male or female patients between 18 to 65 years of age, undergoing liver or kidney transplantation. Female patients of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study. Tacrolimus may reduce the clearance of steroid based contraceptives leading to increased hormone exposure; particular care should be exercised when deciding upon contraceptive measures. Patients should be capable of understanding the purpose and risks of the study, and should provide written informed consent to participate in the study. Inclusion criteria (Specifically for kidney transplant patients) Patients with end stage kidney disease and who are a suitable candidate for primary kidney transplantation. Patients scheduled to receive a kidney transplant from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type. Inclusion criteria (Specifically for liver transplant patients) Patients with end stage liver disease and who are a suitable candidate for primary liver transplantation. Patients scheduled to receive a liver transplant from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type. Exclusion Criteria Details Exclusion Criteria Exclusion Criteria (common to kidney and liver Transplant Patients) Previously received or are scheduled to receive an organ transplant other than kidney or liver. Undergoing re-transplant from either a cadaveric or living donor. Contraindication to the use of tacrolimus or corticosteroids. Malignancy or history of malignancy within the last 5 years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. Systemic infection requiring treatment. Transplantation of kidney or liver from non-heart beating donor. Severe diarrhea, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient. Simultaneously participating in another investigational drug study or has participated in such study within 28 days prior to entry in this study. Receiving any non-registered medication or has received any non-registered medication within 28 days prior to entry in this study. Pregnant women or breast-feeding mother. Patients or respective donors known to be positive for human immunodeficiency virus (HIV). Unlikely to comply with the visits scheduled in the protocol. Exclusion criteria (Specifically for kidney transplant patients) Cold ischemia time of the donor kidney 30 hours. High immunological risk, defined as a positive cross match or PRA grade 50% in the previous 6 months. Liver cirrhosis. page 5 / 7
Significant liver disease, defined as having either elevated serum glutamic pyruvic transaminase / alanine aminotransferase(sgpt / ALT) (at least 2.5 times the upper value of the normal range at the investigational site) or elevated serum glutamic oxaloacetic transaminase/ aspartate transaminase (SGOT/AST) (at least 2.5 times the upper value of the normal range at the investigational site) or elevated total bilirubin levels (at least 2.5 times the upper value of the normal range at the investigational site) or all of them during the 28 days prior to entry into the study. Patients or respective donors known to be positive for hepatitis B virus (HBV) or hepatitis C virus (HCV). Exclusion criteria (Specifically for liver transplant patients) Transplanted for hepatocellular carcinoma with a single nodule greater than 5.0 cm in diameter or more than 3 nodules or metastases or vascular tumoral invasion. Serum creatinine 2mg/dL. Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label Primary Outcome Outcome Timepoints Renal function (evaluated by level of Serum Creatinine) All through out the study from week 1 to week 12 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Time to first biopsy confirmed acute rejection episode Overall frequency of acute rejection episodes Severity of biopsy confirmed acute rejections Incidence of corticosteroid resistant rejection Incidence of corticosteroid sensitive rejection Incidence of use of anti-lymphocyte antibodies Graft loss Death Total Sample Size=200 Sample Size from India=200 31/01/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable Completed None as yet All through out the study from week 1 to week 12 This is a phase IV, open label, multi-centre prospective study of once daily Advagraf in 200 patients undergoing kidney or liver transplantation. Adult patients undergoing kidney or liver transplantation and meeting all the eligibility criteria will be enrolled page 6 / 7
Powered by TCPDF (www.tcpdf.org) REF/2012/01/003173 in the study. Enrolled patients will be administered once daily dose of Advagraf for 12 weeks. During these 12 weeks a total of 9 regular visits will be undertaken. Capsule Advagraf 0.5 mg, 1 mg and 5 mg (modified release tacrolimus) once daily Advagraf is administered in conjunction with other immunosuppressive agents in the initial post-operative period. The dose may vary depending upon the immunosuppressive regimen chosen. page 7 / 7