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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 17:32:44 GMT) CTRI Number CTRI/2012/01/002382 [Registered on: 27/01/2012] - Trial Registered Retrospectively Last Modified On 02/02/2016 Post Graduate Thesis No Type of Trial Observational Type of Study Open label observational study Study Design Single Arm Trial Public Title of Study Study on Cost Components of Continuous Ambulatory Peritoneal Dialysis (CAPD) and Hemodialysis (HD) in India Scientific Title of A Multicentric Observational Pilot Study on Cost Analysis of ongoing Continuous Ambulatory Study Peritoneal Dialysis (CAPD) and Hemodialysis (HD) in India: Patient and Provider Perspectives Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Vivekanand Jha Trial Coordinator (multi-center study) Designation Professor, Department of Nephrology and Head, Depatrment of Translational and Regenerative medicine Affiliation Postgraduate Institute of Medical Education and Research Address Postgraduate Institute of Medical Education and Research Chandigarh Postgraduate Institute of Medical Education and Research Chandigarh Ludhiana PUNJAB 160 012 India Phone 0172-2756733 Fax 0172-2740282 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Rohit Roshan Query) Designation Manager, Medical Affairs Affiliation Baxter (India) Private Limited Address Baxter (India) Private Limited 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase - II, Gurgaon 2nd Floor, Tower-C, Building 8, DLF Cyber City, DLF Phase - II Gurgaon HARYANA 122002 India Phone 0124-4500247 Fax 0124-4263505 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Rohit Roshan Designation Manager, Medical Affairs Affiliation Baxter (India) Private Limited Address Baxter (India) Private Limited 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase - II, Gurgaon 2nd Floor, Tower-C, Building 8, DLF Cyber City, DLF Phase - II Gurgaon page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in HARYANA 122002 India Phone 0124-4500247 Fax 0124-4263505 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase - II, Gurgaon, Haryana - 122002, INDIA Primary Sponsor Primary Sponsor Details Name Baxter India Private Limited Address 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase - II, Gurgaon, Haryana - 122002, INDIA Type of Sponsor Other [Healthcare Industry] Details of Secondary Name Address Sponsor Baxter India Private Limited 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase - II, Gurgaon, Haryana - 122002, INDIA Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Tarun Jeloka Aditya Birla Hospital Senior Consultant, 020-30717821 Department of 020-30717698 Nephrology & Renal [email protected] Transplant Aditya Birla Memorial Hospital,Pune India Aditya Birla Hospital Marg,Chinchwad Pune MAHARASHTRA Dr V Tamilrasi Christian Medical Dept of Nephrology, 0416-2282053 College Unit 1, Christian 0416-2282053 Medical [email protected] College,Vellore, Tamil c.in Nadu - 632004, Vellore TAMIL NADU Dr Arup Ratan Dutta Fortis Hospital & Kidney Department of 033-66276800 Institute Nephrology, 111 A, 033-24634802 Rash Behari Avenue, [email protected] Kolkata 700029. Kolkata WEST BENGAL Dr Ajay Marwaha Kidney Hospital Department of 0181-2243047 Nephrology 63 & 64, 0181-2464666 Waryam Nagar, Cool ajaymarwaha@rediffma Road, Jalandhar 144 il.com 001 Jalandhar PUNJAB DrGeorge Abraham Madras Medical 4-A, Department of 044-26565961 Mission, Nephrology 044-26565959 page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Dr.J.Jayalalitha Nagar, abraham_georgi@yaho Mogappair, Chennai, o.com Tamilnadu-600037, INDIA. Chennai TAMIL NADU Dr Vivekanand Jha Post Graduate Institute Department of Nephrolo 0172-2756733 of Medical Education gy,Postgraduate 0172-2744401 and Research Institute of Medical [email protected] Education & Research Sector-12 Chandigarh CHANDIGARH Dr Amit Gupta Sanjay Gandhi Post Dept. Of nephrology. C 0522-2668700 Graduate Institute of Block ground floor 0522-2668017 Medical Sciences Sanjay Gandhi Post [email protected] Graduate Institute of Medical Sciences, Raebareli road,Lucknow 226014 Lucknow UTTAR PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? ACEAS clinical Approved 03/12/2011 Yes research, Ahmedabad for Fortis, Kolkata ACEAS clinical Approved 03/12/2011 Yes research, Ahmedabad for Kidney Hospital, Jalandhar ACEAS clinical Approved 11/07/2012 Yes research, Ahmedabad, Apollo Victor , Goa Institutional Ethics Approved 10/12/2011 No committee, Aditya Birla Hospital, Pune Institutional Ethics Approved 01/07/2012 No Committee, CARE hosp Institutional Ethics Approved 22/10/2012 No committee, CMC, Vellore Institutional Ethics Approved 27/01/2012 No committee, Madras Medical College, Chennai Institutional Ethics Approved 14/01/2012 No committee, PGIMER, Chandigarh Institutional Ethics Approved 18/04/2012 No committee, SGPGI, Lucknow Regulatory Clearance Status Date Status from DCGI Notified 01/11/2011 Health Condition / Health Type Condition Problems Studied Patients The study is an observational study and will page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in require Early Stage Renal Disease (ESRD) patients who are already on Hemo dialysis or Peritoneal dialysis. Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Patients should be between 18-65 years of age <br/> 2.Patients should have completed minimum of 3 months on one mode of dialysis <br/> 3. Patients who are on HD for at least 10 sessions a month (prevalent practice) <br/> 4. Patients undergoing CAPD with at least 3 exchanges per day (prevalent practice) <br/> 5. Patients on dextrose based solutions for CAPD <br/> 6. Patients shifted from another renal replacement therapy but have completed 3 months on new modality <br/> 7. Patient willing to give informed consent <br/> Exclusion Criteria Exclusion Criteria Details 1. Patients who are on dialysis for less than 3 months 2. Patients on Automated Peritoneal Dialysis 3. Patients using Extraneal as exchange fluid for PD 4. Patients with Hepatitis B & C and HIV infection 5. Patients having Charlson Co-morbidity index 5 6. Patients with mental or neurological disorders, that might make their survey questionable 7. Patients unwilling to cooperate 8. Patients with expected life expectancy less than 1 year 9. Pregnancy and women of child bearing age who are planning for conception in next 12 months (duration of the study) 10. Patients under any reimbursement or health insurance scheme without proper supporting bills 11. Patient expected to be transferred to a non participating center within the period of study 12. Patients who previously have received kidney transplant or intend to receive kidney transplant in next 3 months 13. Patients with concomitant participation in any other interventional study Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Cost of ongoing HD versus CAPD therapy per Week 12, week 24, week 36 and week 48 year to patient & family (Direct & Indirect) Secondary Outcome Outcome Timepoints User satisfaction with HD and PD therapy Week 12, Week 24, Week 36 and Week 48 Cost Utility of CAPD versus HD therapy in one year Target Sample Size Total Sample Size=80 Sample Size from India=80 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Phase of Trial N/A Date of First 30/11/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Brief Summary The study is a non randomized, open label, parallel arm, multi-centre trial is an observational pilot study on cost analysis of ongoing continuous ambulatory peritoneal dialysis and haemodialysis in India taking into account the patient and provider perspectives, that will be conducted in eight centers in India. The primary outcome will be analyses of the annual maintenance cost of care for HD and CAPD to patients & family and the capital & recurring cost of infrastructure, manpower and skills to providers in public and private hospitals. The secondary outcomes will be QOL measured by EQ5D, Cost per quality-adjusted life year in HD and CAPD therapy, Cost Utility ratio of CAPD versus HD and Frequency of Complications, Hospitalizations and Rehabilitation page 5 / 5 Powered by TCPDF (www.tcpdf.org).
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