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1 Clinical Trial Details (PDF Generation Date :- Mon, 17 Dec :42:46 GMT) CTRI Number Last Modified On 07/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/11/ [Registered on: 21/11/2011] - Trial Registered Prospectively No Interventional Biological Other A clinical trial to assess the safety of new erythropoietin in chronic kidney disease patients on Haemodialysis. A phase I/II, open label, single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in chronic kidney disease patients who are on haemodialysis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) PSAEPO: 01/11 Version 5.0 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Sajjad Desai Deputy Director Phone Fax Designation Affiliation Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. 212/2, Off Soli Poonawalla road, Hadapsar,, India India sajjad.desai@seruminstitute.com Details Contact Person (Public Query) Dr Sajjad Desai Deputy Director Phone Serum Institute of India Pvt. Ltd. Serum Institute of India Pvt. Ltd. 212/2, Off Soli Poonawalla road, Hadapsar,, India India page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax > Serum Institute of India Ltd Type of Sponsor NA List of Countries India of Principal Investigator Dr Deepak Dewan Source of Monetary or Material Support Primary Sponsor Details Serum Institute of India Pvt Ltd 212/2, Off Soli Poonawalla road, Hadapsar, ,, India Pharmaceutical industry-indian NA of Site Site Phone/Fax/ Ajantha Research Centre Dr Mahesh C Chaya Hospital Chaya Hospital, No. 6C-335, 4th C Main Road, 6th Cross, OMBR Layout, Bhuvanagiri, Bangalore , Karnataka. Bangalore KARNATAKA Dr Charulata Bawankule Dr Satish Balan Dr Georgi Abraham Government Medical College and Hospital Kerala Institute of Medical Sciences Madras Medical Mission Ajanta Research Centre, Ajanta Hospital and IVF Centre, 765, drdeepakdewan@rediff ABC Complex, Kanpur mail.com R Alambagh, Lucknow Lucknow UTTAR PRADESH doccm2000@yahoo.co m Super speciality hospital, Government Medical College & pk52kule@yahoo.com Hospital Tukdoji Square, Nagpur Nagpur Kerala Institute of Medical Sciences, P B No. 01, Anayara P O, Trivendrum , Kerala. Thiruvananthapuram KERALA Madras Medical Mission, No. 4 A, Dr J J Nagar, Mogappair, Chennai, Chennai TAMIL NADU Dr Avinash Ignatius Noble Hospital Noble Hospital, 153, Magarpatta City Road, balansatish@rediffmail. com abraham_georgi@yaho o.com dr_ignatius@yahoo.co.i page 2 / 6

3 Details of Ethics Committee Dr Abhay Gopal Huprikar Dr Deodatta Chafekar Dr Apurva Parekh Dr Hansraj Alva Ruby Hall Clinic Shatabdi Super Speciality Hospital Shrushrut Clinical Research Association Vinaya Hospital & Research Centre Grant Medical Foundation, Ruby Hall Clinic, 40, Sassoon Road, Shatabdi Super speciality hospital, Sujoyit square, Mumbai Naka, Nasik Nashik 4th Floor, Shrushrut Clinical Research Association, Kidney Diseases and Transplant Foundation, Shubham Superspeciality Hospital, Opp. Bank of Baroda, Near Sardar Patel Statue, Sardar Patel colony. Naranpura, Ahmedabad , Gujarat,India Ahmadabad GUJARAT Vinaya Hospital & Research Centre, Department of Medicine, Consulting Physician, Medical Director, PO Box 717, Karangalpady, Mangalore , Karnataka, India Dakshina Kannada KARNATAKA n abhayhuprikar@gmail.c om nchafy@hotmail.com drapoorva@hotmail.co m drhansrajalva@yahoo.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? Astha Independent Poona Medical College Foundation IEC-ARC Institutional Approved 14/09/2013 Yes Approved 16/12/2013 No Approved 28/12/2014 No Institutional Ethics Approved 19/03/2015 No Committee Govt. Medical College Nagpur Institutional Ethics Committee The Madras Medical Mission Institutional Human Ethical Committee Approved 27/11/2013 No Approved 23/05/2013 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Kerala Institute of Medical Sciences Mallikatta Ethics Committee Medisys Clinisearch Ethical Review Board Noble Hospital Institutional Ethics Committee Shatabdi Hospital Status Approved 26/07/2013 Yes Approved 29/11/2014 No Approved 26/12/2013 No Approved 23/02/2015 No Date Approved/Obtained 03/07/2013 Health Type Patients Condition Patients with chronic kidney disease who are on haemodialysis Type Details Intervention Polysialylated Erythropoietin Polysialylated erythropoietin formulation, which is a performance-enhanced polysialylated form of erythropoietin. It is being developed for the treatment of anaemia in patients who are on dialysis. Polysialylated erythropoietin will be administered intravenously. Study drug will be administered one time on Day I and subject will be followed through Day 28. Comparator Agent Not Applicable Not Applicable Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria 1. Subjects willing to give voluntary written informed consent. 2. Males? 18 and? 70 years of age and post-menopausal Females? 70 years of age. 3. Clinically stable on hemodialysis for? 3 months before screening (3 sessions per week). 4. Subjects with adequate dialysis ( as determined by Kt/V?1.2 or URR?65%) before enrollment. 5. Hemoglobin value of?8g/dl and? 11 g/dl within 14 days prior to administration of study drug 6. Serum ferritin level? 200 µg/l and transferrin saturation? 20% within 14 days prior to administration of study drug 7. RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug. Exclusion Criteria 1. Has received erythropoiesis stimulating agent in the last 6 weeks. 2. Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study. 3. Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types], page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label hemolysis, vitamin B12 or folic acid deficiency) 4. History suggestive of pure red cell aplasia (PRCA) 5. C Reactive Protein (CRP) greater than 15 mg/dl within 14 days prior to administration of study drug 6. Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening. 7. Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic? 170 mm Hg, diastolic? 100 mm Hg on repeat readings) 8. Known intolerance to parenteral iron supplementation Primary Outcome Outcome Timepoints Assessment of Safety (Vital signs, physical examination & ECG, Monitoring of adverse events, Clinical laboratory assessments) of polysialylated erythropoietin administered through IV route. On Day 1, Day 7, Day 14 and Day 28 post dose. Secondary Outcome Outcome Timepoints Target Sample Size 1. Pharmacokinetic Endpoints Cmax, Tmax, AUC0-t, AUC0-?, t1/2 and Kel 2. Pharmacodynamic Endpoints Absolute & percent Reticulocyte count Reticulocyte hemoglobin(chr) Haemoglobin, RBC count Hematocrit 3. Immunogenicity Endpoints Anti-polysialylated erythropoietin antibodies Anti-erythropoietin antibodies Anti-polysialic acid antibodies. Total Sample Size=40 Sample Size from India=40 Phase of Trial Phase 1/ Phase 2 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 20/12/2011 No Date Specified Years=0 Months=6 Days=0 Not Applicable Completed Nil Pharmacokinetics : Pre-dose and 0.25, 1, 2,6,24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose. Pharmacodynamics: Pre-dose and 24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose. Immunogenicity: Pre-dose and on Day 28 post-dose. A Phase I/II, Open label, Single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in 40 hemodialysis patients. Four intravenous doses of polysialylated erythropoietin (0.5 mcg/kg, 1.5 mcg/kg, 3.0 mcg/kg and 4.5 mcg/kg body weight) are planned to be investigated. Forty subjects will be enrolled into the study in four cohorts of ten subjects each. All subjects will be followed up for a period of 28 days to assess safety, page 5 / 6

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