CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 23:35:33 GMT) CTRI Number CTRI/2012/03/002501 [Registered on: 19/03/2012] - Trial Registered Prospectively Last Modified On 12/11/2018 Post Graduate Thesis No Type of Trial BA/BE Type of Study Study Design Randomized, Crossover Trial Public Title of Study A study to demonstrate the equivalence of Sevelamer carbonate tablet 800 mg, (Test Drug) with Renvela® 800 mg (Reference drug)in adult patients of hyperphosphataemia receiving haemodialysis. Scientific Title of A Crossover, Multicentric Randomized study, in adult patients of hyperphosphataemia receiving Study haemodialysis to demonstrate equivalence of Sevelamer carbonate tablet 800 mg, manufactured by Pharmathen S.A. (Test Drug) with Renvela® 800 mg. (Sevelamer carbonate 800 mg, Genzyme Europe B.V, Gooimee 10,1411 DD Naarden The Netherlands) Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Kshitij Soni Trial Coordinator (multi-center study) Designation Project Manager Affiliation Lambda Therapeutic Research Ltd. Address Lambda Therapeutic Research Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Lambda Therapeutic Research Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Ahmadabad GUJARAT 380 061 India Phone 91-79-40202322 Fax 91-79-40202022 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Praveen shetty Query) Designation Assitant manager Affiliation Lambda Therapeutic Research Ltd. Address Lambda Therapeutic Research Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Lambda Therapeutic Research Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Ahmadabad GUJARAT 380 061 India Phone 91-79-40202098 Fax 91-79-40202022 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ankit Ranpura Designation Assitant manager Affiliation Lambda Therapeutic Research Ltd. page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Address Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Lambda Therapeutic Research Ltd Near Gujarat High Court, S.G. Highway, Gota, Ahmedabad, Gujarat-380 061, India Ahmadabad GUJARAT 380 061 India Phone 91-79-40202098 Fax 91-79-40202022 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Pharmathen S.A. Dervenakion str., 153 51 Pallini, Athens-Greece Primary Sponsor Primary Sponsor Details Name Pharmathen SA Dervenakion str Address 153 51 Pallini, Athens-Greece Type of Sponsor Pharmaceutical industry-Global 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 Dr Sonal Dalal Gujarat Kidney 5th Floor, Shaival 9825008924 Foundation Complex, Near Suvidha Shopping Centre, [email protected] Between Parimal m Crossing and Mahalaxmi Char Rasta,Paldi, Ahmedabad-380007, Gujarat, India Ahmadabad GUJARAT Dr H L Trivedi IKDRC, Ahmedabad. Smt. G. R. Doshi & 9998810145 Smt. K. M. Mehta Institute of Kidney drpankajrshah@yahoo. Diseases & Research com Centre & Dr. H.L. Trivedi Institute of Transplantation Sciences (ITS) B. J. Medical college & Civil Hospital Campus, Asarwa, 380016 Ahmadabad GUJARAT Dr Bhavin Mehtalia Kidney Disease and C/O, Shubham 9825294429 Transplantation Superspeciality Foundation Hospital, 4th Floor [email protected] (402-404), Sardar Patel om Colony, Near Bank of Baroda, Naranpura, Ahmedabad- 380013 Ahmadabad page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in GUJARAT Dr Umesh Khanna Lancelot GI & Kidney 111/C, S.V. Road, 02228016266 Centre Borivali (west), Mumbai-400092, [email protected] Maharashtra Mumbai MAHARASHTRA Dr Vishwanath Siddini Manipal Hospital 98 HAL Airport road, 080-25204631 Banglore-560017, Karnataka siddinivishwanath@hot Bangalore mail.com KARNATAKA Dr Ishtiaque Ahmed Narayana hrudayala 258/A Bommasandra 08022142139 hospitals Industrial area Anekal,Taluk, Banglore [email protected] 560099, Karnataka Bangalore KARNATAKA Dr Manish Sahay QQDC Building Osmania General 040-24606687 Hospital, Afzalganj, Hyderabad-12, A.P. drmanishasahay@gmai Hyderabad l.com ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? "Gujarat Kidney Approved 13/02/2012 No Foundation Ethics Committee Ethiclin Independent Approved 15/02/2012 Yes Ethics Committee, Upper-14, Ratnadeep Towers, Opp. C.P. Nagar, Ghatlodiya, Ahmedabad-61, Gujarat, India Ethics Committee of Approved 19/04/2012 No Manipal Hosptial Institutional Ethics Approved 14/05/2012 No Committee, Osmania Medical College koti,Hyderabad-500095, Andhra Pradesh, India. Lancelot Independent Approved 23/07/2012 Yes Ethics committee Narayana Hrudayala Approved 28/03/2012 No Medical Ethics Committee The Internal Review Approved 16/04/2012 No Board Institute of Kidney Diseases and Research Centre & Dr.H.L. Trivedi Institute of Transplantation Sciences Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in Health Condition / Health Type Condition Problems Studied Patients Disorders of phosphorus metabolismand phosphatases Intervention / Type Name Details Comparator Agent Intervention Sevelamer carbonate tablet 800 The recommended starting mg, manufactured by dose of Sevelamer carbonate is Pharmathen S.A. 800 to 1600 mg, which can be administered as one or two Sevelamer carbonate 800 mg Tablets, with meals based on serum phosphorus level. Following table provides recommended starting doses of Serum Phosphorus Sevelamer 800 mg 5.5 and 7.5 mg/dL 1 tablet three times daily with meals ? 7.5 and 9.0 mg/dL 2 tablets three times daily with meals ?9.0 mg/dL 2 tablets three times daily with meals Comparator Agent Renvela® 800 mg. (Sevelamer The recommended starting carbonate 800 mg dose of Sevelamer carbonate is 800 to 1600 mg, which can be administered as one or two Sevelamer carbonate 800 mg Tablets, with meals based on serum phosphorus level. Following table provides recommended starting doses of Serum Phosphorus Sevelamer 800 mg 5.5 and 7.5 mg/dL 1 tablet three times daily with meals ? 7.5 and 9.0 mg/dL 2 tablets three times daily with meals ?9.0 mg/dL 2 tablets three times daily with meals Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Informed consent should be obtained before any trial-related activities. 2. Male or female aged ?18 years. 3. Patients who are eligible for Sevelamer carbonate as per principal Investigator discretion. 4. Patient should have the following documented laboratory measurements: - Two most recent consecutive serum phosphorus measurements that are ? 3.0 and ? 7.5 mg/dL within 60 days of screening - An most recent iPTH measurement ? 900 pg/mL (< 99 pmol/L) within 90 days of screening - A serum phosphorus measurement ? 5.5 mg/dL (? 1.76 mmol/L at local lab) at Visit 2 (after Washout period and before run-in period) Exclusion Criteria Exclusion Criteria Details 1. Known hypersensitivity to Sevelamer or any of its components 2. Pregnant, breast-feeding female 3. Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders. 4. Have any evidence of active malignancy except for basal cell page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in carcinoma of the skin. A history of malignancy is not an exclusion 5. Have participated in a study of an investigational drug during the 30 days preceding the start of the run in period Method of Generating Stratified randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints To compare the therapeutic equivalence of NA Sevelamer carbonate tablets (Test drug) with Renvela (Sevelamer Carbonate Tablets) on the control of serum phosphorus level Secondary Outcome Outcome Timepoints To monitor the safety of the patients who are NA exposed to investigational medicinal products Target Sample Size Total Sample Size=80 Sample Size from India=80 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 Phase 3 Date of First 25/04/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Other (Terminated) Trial (India) Publication Details Brief Summary A Crossover, Multicentric Randomized study, in adult patients of hyperphosphataemia receiving haemodialysis to demonstrate equivalence of Sevelamer carbonate tablet 800 mg, manufactured by Pharmathen S.A. (Test Drug) with Renvela® 800 mg. (Sevelamer carbonate 800 mg, Genzyme Europe B.V, Gooimee 10,1411 DD Naarden The Netherlands). Primary Objective: To compare the therapeutic equivalence of Sevelamer carbonate tablets (Test drug) with Renvela (Sevelamer carbonate tablets) on the control of serum phosphorus level. Secondary Objectives;The time-weighted

Load more