REFCTRI/2010/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Thu, 09 Mar :03:13 GMT) CTRI Number CTRI/2010/091/ [Registered on: 04/02/2011] - Last Modified On 23/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Other An EpiDemiological Study Evaluating AbdoMinal AOrta CalcificatioN ScoreS in End STage Renal Disease IndiAn PatienTs New to HEmodialysis (DEMONSTRATE) To assess abdominal aorta calcification (AAC) in End Stage Renal Disease patients new to hemodialysis through Abdominal Aorta Calcification Score (AACS) using lateral abdominal X-Ray. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL Designation Affiliation NIL Details of Principal Investigator Dr. Georgi Abraham Phone Fax Designation Affiliation Madras Medical Mission 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai TAMIL NADU abraham_georgi@yahoo.com Details Contact Person (Scientific Query) Dr. Mohanasundaram Senthilnathan Medical Director, Phone Fax Designation Affiliation Genzyme Pvt. Ltd. 1st Floor, Technopolis, Golf Course Road, Sector-54Gurgaon senthilnathan.mohanasundaram@genzyme.com Details Contact Person (Public Query) Dr. Georgi Abraham Phone Fax Madras Medical Mission 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai TAMIL NADU page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Primary Sponsor: Dr. Georgi Abraham Madras Medical Mission 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai Telephone: ext: 2800 Secondary Sponsor: Genzyme Pvt. Ltd., 1st Floor, Technopolis, Golf Course Road, Sector-54, Gurgaon , Haryana Type of Sponsor Genzyme Pvt. Ltd., 1st Floor, Technopolis, Golf Course Road, Sector-54, Gurgaon , Haryana Max Neeman Medical International Limited, Max House, 1, Dr. Jha Marg Okhla Phase III New Delhi List of Countries of Principal Investigator Dr. Pradeep Salgia Dr. Prakash Darji Primary Sponsor Details Dr. Georgi Abraham Madras Medical Mission 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai Telephone: ext: 2800 of Site Site Phone/Fax/ Dr. Pradeep Salgia Clinic Gujarat Kidney Foundation 9/5, Manoramaganj, Opp St Paul Primary School, Indore , Dr. Tonmoy Das International Hospital, International Hospital, Lotus Tower, G.S Road, Guwahati? , Dr. Hemant Mehta Dr Abi Abraham M King Edward Memorial Hospital Lakeshore Hospital and Research Centre psalgia@rediffmail.com Gujarat Kidney Foundation, 4-5th Floor, drprakashdarji@hotmail Shaival Complex,,Near.com Suvidha Shopping Centre, Between Parima Crossing & Mahalaxmi Char Rasta, Paldi, tonmoydas@rediffmail. com King Edward Memorial Hospital (KEM),Acharya drhmehta@hotmail.com Donde Marg, Parel, Mumbai , Mumbai, Lakeshore Hospital and Research Centre Ltd, NH 47 By-pass, dr.abiabraham@gmail.c om page 2 / 6

3 Dr. Umesh B Khanna Dr.Georgi Abraham Dr. Dinesh Mittal Lancelot Kidney & GI Centre Madras Medical Mission Maharaja Aggarsen Hospital Dr. K.V. Dakshinamurty Nizam's Institute of Medical Sciences Maradu,,Nettoor P.O., Kochi Lancelot Kidney & GI Centre 111C Lancelot, S.V. Road, Borivili (West), Mumbai , Madras Medical Mission, 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai ,, Maharaja Aggarsen Hospital,,Punjabi Bagh West,- New Delhi DELHI Nizam's Institute of Medical Sciences,,Punjagutta, Hyderabad? Dr Abhay. N. Sadre Noble Hospital Noble Hospital, 153,,Magarpatta City Rd, Hadapsar, Dr. Vivekanand Jha Dr. S Saxena Dr. Deepak Shankar Ray Dr. R K Sharma Postgraduate Institute of Medical Education and Research (PGIMER) Pushpawati Singhania Research Institute Rabindranath Tagore International Institute of Cardiac Sciences & Armenian Church Trauma Center Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Stem Cell Research Facility, PGIMER. Secretary, n Society of Nephrology,- PSRI Hospital,Press Enclave Marg,,Sheikh Sarai- II, New Delhi New Delhi DELHI R.N.Tagore International Inst., 124 Mukundapur.E.M Bypass, Kolkata? , Senior Professor and,- Dr. Gokulnath St. John's Medical St. John's Medical molina@vsnl.com abraham_georgi@yaho o.com dinemitt@rediff.com kvdm1954@gmail.com drsadre@gmail.com vjha@pginephro.org;vjh a60@gmail.com drsanjivsaxena@rediff mail.com deepak_ray@hotmail.c om rksharma@sgpgi.ac.in page 3 / 6

4 Details of Ethics Committee College & Hospital College & Hospital, Sarjapur Road, Bangalore?,Sarjapur Road, Bangalore? Bangalore KARNATAKA uk of Committee Approval Status Date of Approval Is Independent Ethics Committee? CLINICOM, Independent Ethics Committee CLINICOM, Independent Ethics Committee Ethics Committee, Pushpawati Singhania Research Institute& Hospital, Ethics Committee, Rabindranath Tagore International Institute of Cardiac Sciences & Armenian Church Trauma Center, 124 Mukundapur.E.M Bypass, Kolkata? Committee, Committee,,Lakeshore Hospital and Research Centre Ltd, NH 47 By-pass, Maradu, Nettoor P.O., Kochi Approved Approved Approved 15/03/2011 Committee, Gujarat Kidney Foundation, 4-5th Floor, Shaival Complex, Near Suvidha Shopping Centre, Between Parima Crossing & Mahalaxmi Char Rasta, Paldi, Ahmedabad Approved 28/02/2011 No Committee, International Hospital, Lotus Tower, G.S Road, Guwahati? Committee, King Edward Memorial Hospital (KEM),Acharya Donde Marg, Parel, Approved 20/04/2011 No page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Mumbai Committee, Madras Medical Mission, 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai , Approved 25/03/2011 No Committee, Maharaja Aggarsen Hospital, Committee, Noble Hospital, 153, Magarpatta City Rd, Hadapsar, Pune Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Committee, St. Johns Medical College & Hospital, Sarjapur Road, Bangalore? , Postgraduate Institute of Medical Education and Research (PGIMER) Status Health Type Approved Approved 30/04/2011 No Approved 15/03/2011 Date Condition End Stage Renal Disease n Patients Type Details Intervention Nil Nil Comparator Agent Nil Nil Age From Age To Gender Details Inclusion Criteria 1. Male and female patient aged > 18 years. 2. Diagnosed with ESRD and on hemodialysis for at least 4 weeks and maximum of 3 months prior to the signing of the informed consent. 3. The patient must be willing and able to provide written informed consent. 4. If female of child-bearing potential, must have a negative urine/serum pregnancy test. Otherwise, females must have been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year Exclusion Criteria Details 1. Pregnant or breast feeding women. 2. Stage I-IV CKD patients. 3. ESRD patients not on hemodialysis 4. Patients on peritoneal dialysis page 5 / 6

6 Powered by TCPDF ( REFCTRI/2010/ Method of Generating Random Sequence Method of Concealment Blinding/Masking 5. Unable to comply with study requirements. 6. The patient has any clinically significant disease, other than ESRD or other medical conditions, or serious intercurrent illnesses that, in the opinion of the Investigator, may preclude participation in the study. 7. Any other medical/surgical condition, which in the opinion of the investigator and/or radiologist could interfere with conduct of the lateral lumbar X-ray. 8. Patient has previously undergone kidney transplant. Primary Outcome Outcome Timepoints To assess abdominal aorta calcification (AAC) in End Stage Renal Disease (ESRD) patients new to hemodialysis through Abdominal Aorta Calcification Score (AACS) using lateral abdominal X-Ray A period of approximately 12 months is anticipated from the time the first patient is enrolled in the study to the completion of the study (last patient out). Each patient?s duration of participation in this epidemiological study is for a maximum of 7 days from the time informed consent is provided by the patient (or discontinuation / withdrawal). Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Nil Total Sample Size=1500 Sample Size from = 20/01/2011 Years=1 Months=0 Days=0 Closed to Recruitment of Participants This is a prospective, multicentric, epidemiological study in approximately 1500 patients with ESRD that are new to hemodialysis. Patients who have been diagnosed with ESRD and on hemodialysis for at least 4 weeks and maximum of 3 months prior to the signing of the informed consent shall be recruited in this study. No study drug will be administered in this epidemiological study. Therefore, efficacy will not be assessed during this epidemiological study. Nil page 6 / 6

REF/2011/03/002226 CTRI Website URL - http://ctri.nic.in

REF/2011/03/002226 CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 14 Jul 2016 15:20:58 GMT) CTRI Number Last Modified On 28/01/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study