PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 06:54:45 GMT)
CTRI Number CTRI/2014/12/005341 [Registered on: 31/12/2014] - Trial Registered Prospectively Last Modified On 15/05/2017 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study Evaluation of Efficacy and Safety of Hydroxychloroquine in type-II diabetes patients with chronic kidney disease. Scientific Title of A Dose Ranging Study to Evaluate the Role of Hydroxychloroquine in Preserving the Kidney Study Function by Slowing Down the Progression of Kidney Disease Due to Type-II Diabetes. Secondary IDs if Any Secondary ID Identifier Ipca/LHCQ/PII-12, Version No. 2, dated Protocol Number 28/02/2014 Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address
Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Anil Pareek Query) Designation President, Medical Affairs and Clinical Research Affiliation Ipca Laboratories Ltd Address Ipca Laboratories Ltd, 142AB Kandivli Industrial Estate Kandivli(W) Mumbai Mumbai MAHARASHTRA India Mumbai (Suburban) MAHARASHTRA 400067 India Phone 02266474641 Fax 02228686954 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Nitin Chandurkar Designation General Manager Affiliation Ipca Laboratories Ltd Address Ipca Laboratories Ltd, 142AB Kandivli Industrial Estate Kandivli(W) Mumbai Mumbai MAHARASHTRA India Mumbai (Suburban) MAHARASHTRA 400067 India Phone 02261112318
page 1 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
Fax 02228686954 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ipca Laboratories Ltd. Mumbai Primary Sponsor Primary Sponsor Details Name Ipca Laboratories Ltd Mumbai Address 142AB, Kandivli Industrial Estate, Kandivli(W),Mumbai,Maharashtra-400067 Type of Sponsor Pharmaceutical industry-Indian 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 Deepak Dewan Ajanta Hospital and IVF No.765, Near Krishna 9936507362 Centre Cinema,Kanpur Road Alambagh, Lucknow, drdeepakdewan@rediff UP-226005 mail.com Lucknow UTTAR PRADESH Dr Sanjay Agarwal All India Institute of Department of 9868397402 Medical Sciences Nehprology,All India Institute of Medical skagarwalnephro@gma Sciences, Ansari il.com Nagar, New Delhi – 110 029 North DELHI DrGPrasad Andhra Medical College Department of 9848238292 and King George Nephrology,Andhra Hospital Medical College and [email protected] King George Hospital, om Jagadamba Area,KGH,Down Road, Maharanipeta,Visakhap atnum-530002 Visakhapatnam ANDHRA PRADESH Dr Nisith Kumar Apollo Hospital, Consultant, Department 9337103451 Mohanty Bhubaneswar of Nephrology,Apollo Hospital,Plot No.251, [email protected] Old Sainik School n Road, Bhubaneswar-750015 Khordha ORISSA Dr Pratim Sengupta Belle Vue Clinic,Kolkata Consultant, Department 9830099686 of Nephrology Belle Vue Clinic,9, Dr. U.N. pratim.sengupta@gmail Brahmachari .com Street,Kolkata-700017 Kolkata WEST BENGAL DrNandita Choudhury Down Town Consultant, Department 9435191927
page 2 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
Hospital,Dispur, of Nephrology,Down Guwahati Town Hospital,GS dr.nanditachoudhury@r Road Dispur,Guwahati- ediffmail.com 781006 Kamrup ASSAM Dr Farah Ingale Fortis Hirannadani Sec 10 (A), Mini Sea 9820518370 Hospital Shore Road,Vashi, Mumbai [email protected] Mumbai (Suburban) m MAHARASHTRA Dr JS Kushwaha Ganesh Shankar Professor Department 9415040752 Vidyarthi Memorial of Medicine, Ganesh Medical College,Kanpur Shakar Vidyarthi [email protected] Memorial Medical om College Swaroop Nagar Kanpur-208002, U.P. Kanpur Nagar UTTAR PRADESH Dr M Sreelatha Government Medical Department of 9446338109 College, Kozhikode Nephrology, Government Medical [email protected] College, Kozhikode - 673008 Kozhikode KERALA Dr Surinder Salwan Government Medical Assistant Professor 9417055008 College,Amritsar Department of Medicine, Government surindersalwan05@gm Medical ail.com College,Circular Road, Amritsar-143001 Amritsar PUNJAB Dr Rajendra Pandey IPGME&R and SSKM Department of 9831096910 Hospital, Kolkata Nephrology, IPGME&R and SSKM Hospital, rajensankrityan@gmail. 244, A. J. C. Bose com Road, Kolkata-700020 Kolkata WEST BENGAL Dr Anil Godbole KEM Hospital Research Department of 9422037431 Centre, Pune Medicine, unit of Nephrology, K E M dranilgodbole@rediffma Hospital, Rastha Peth il.com road, Pune- 411011 Pune MAHARASHTRA Dr MLPatel King George Medical Department of 9415154510 University Nephrology,Shah Mina Road, Chowk-226003 [email protected] Lucknow UTTAR PRADESH Dr Manjuri Sharma Marwari Hospital and Consultant, Department 9435553482 Research Centre of Nephrology Marwari Guwahati Hospital and Research manjurisharma@yahoo. Centre, S.J. Road Athg com aon,Guwahati-781008 Golaghat
page 3 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
ASSAM Dr K Sampathkumar Meenakshi Mission Department of 9994872250 Hospital, Mdurai Nephrology, Meenakshi Mission Hospital and [email protected] Research Centre, Melur m Road, Madurai 625107 Madurai TAMIL NADU DrPinaki Mukhpadhyay Nil Ratan Sirkar Department of 9231978078 Medical College and Nehprology, 138, Hospital AJC,Bose [email protected] Road,Sealdah, Kolkata-700014 Kolkata WEST BENGAL Dr D Sree Bhushan Nizam’s Institute of Department of 9848492951 Raju Medical Sciences, Nephrology, Nizam’s Hyderabad Institute of Medical sreebhushan@hotmail. Sciences, Panjagutta, com Hyderabad-500082 Hyderabad ANDHRA PRADESH Dr Manju Thampi Noorul Islam Institute of Department of 9847101301 Medical Sciences, Nephrology, Noorul Trivandrum Islam Institute of drmanjuthampi@gmail. Medical Sciences and com Hospital NIMS Medicity, Trinadrum Thiruvananthapuram KERALA Dr KL Gupta Post Graduate Institute Professor and Head 9417249922 of Medical Education Department of and Research Nephrology,Post [email protected] Graduate Institute of Medical Education and Research, Sec-12,Chan digarh-160012 Chandigarh CHANDIGARH Dr Raj Kumar Sharma Sanjay Gandhi Post Department of 9415026762 Graduate Institute of Nephrology, Sanjay Medical Sciences, Gandhi Post Graduate [email protected] Lucknow Institute of Medical Sciences, Raebareli Road, Lucknow - 226014 Lucknow UTTAR PRADESH Dr Vinay Malhotra SMS Medical College Department of 9828018762 and Hospital, Jaipur Nephrology, SMS Medical College and [email protected] Hospital, Jawaharlal Nehru Marg, Jaipur - 302004 Jaipur RAJASTHAN Dr Georgi Abraham The Madras Medical Director and HOD, 044-26565961 Mission Chennai Department of Nephrology,The abraham_georgi@yaho
page 4 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
Madras Medical o.com Mission 4-1 Dr. Jayalalitha Nagar Mogappair, Chennai-600037 Chennai TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Commitee, Approved 27/03/2015 No Noorul Islam Institute of Medical Sciences (NIMS), Trivandrum Ethics Committee Approved 01/09/2015 No Apollo Hospital Bhubaneswar Ethics Committee Down Approved 07/03/2015 No Town Hospital Guwahati Ethics Committee Approved 01/10/2015 No GSVM Medical College Kanpur Ethics Committee Approved 17/06/2015 No Hiranandani Hospital, Mumbai Ethics Committee, Approved 30/04/2015 No Government Medical College, Kozhikode Ethics Committee, Approved 26/11/2014 No S.M.S. Medical College and attached Hospitals, Jaipur Ethics Committee-The Approved 28/12/2015 No Madra Medical Mission Hospital Ethics Approved 01/10/2015 No Committee Marwari Hospital Instituinal Human Approved 19/12/2014 No Ethics Committee, Meenakshi Mission Hospital, Madurai Instituional Ethics Approved 04/04/2015 No Committee, King George Hospital, Viskhapatnam Instituional Ethics Approved 21/07/2015 No Committee, King George Medical University, Lucknow Instituional Ethics Approved 12/05/2015 No Committee, NRS Medical COllege Kolkata Institute of Ethics Approved 26/09/2014 No Committee, All India Institute of Medical Sciences
page 5 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
Institutional Ethics Approved 08/02/2016 No COmmittee Belle Vue Clinic Kolkata Institutional Ethics Submittted/Under No Date Specified No Committee Goernment Review Medical College Amritsar Institutional Ethics Submittted/Under No Date Specified No Committee Post Review Graduate Institute Medical Education and Research Chandigarh Institutional Ethics Approved 31/12/2014 No Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow Institutional Ethics Approved 10/05/2015 No Committee,Ajanta Hospital and IVF Centre Lucknow IPGME&R Research Approved 26/11/2014 No Oversight Committee, Kolkata KEM Hospital Research Approved 26/05/2015 No Centre Ethics Committee, Pune NIMS Institutional Approved 15/09/2015 No Ethics Committee, Hyderabad Regulatory Clearance Status Date Status from DCGI Approved/Obtained 12/08/2014 Health Condition / Health Type Condition Problems Studied Patients Type-II diabetes with Chronic Kidney Disease Intervention / Type Name Details Comparator Agent Intervention Hydroxychloroquine 1. Hydroxychloroquine tablet Dose-100mg, 2. Hydroxychloroquine tablet Dose - 150mg 3. Hydroxychloroquine tablet Dose - 200mg Fequency -OD, Duration-52weeks and route- PO Comparator Agent Placebo of Hydroxychloroquine 1. Placebo of Hydroxychloroquine tablet Dose - 100mg 2. Placebo of Hydroxychloroquine tablet Dose - 150mg 3. Placebo of Hydroxychloroquine tablet Dose - 200mg Fequency -OD, Duration-52weeks and route- PO Inclusion Criteria Inclusion Criteria Age From 30.00 Year(s) Age To 75.00 Year(s) Gender Both
page 6 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
Details General Health
1.Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
Conditions under study
2.Patients with moderately decreased eGFR (30-59 mL/min per 1.73 m2) calculated using abbreviated Modification of Diet in Renal Disease [aMDRD] and having type II diabetes (HbA1c value ?7% and ? 10%).
Compliance
3.Patient must understand and be able, willing and likely to fully comply with study procedures and restrictions.
4.Patients ready to undergo a follow-up period of 56weeks.
Informed Consent
5.Patient must have given written, personally signed and dated, informed consent to participate in the study, in accordance with the current applicable regulations, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, before initiating any study related procedures.
Exclusion Criteria Exclusion Criteria Details 1.Patients with kidney failure i.e. end stage renal disease (ESRD) requiring dialysis or renal transplantation). 2.Patients with proteinuria 3.0 g/24 hour. 3.Patients with diastolic blood pressure (DBP) ? 110 mmHg. 4.Patients with type I diabetes. 5.Patients with abnormal ECG and/or history of significant cardiovascular disease 6.Patients with non-diabetic kidney disease. 7.Patients with hyperkalemia (serum potassium 5.5 mEq/L) or requiring treatment with drugs known to increase serum potassium levels. 8.Patients with history of myopathy or neuromyopathy. 9.Patients with unilateral or bilateral renal artery stenosis. 10.Patients with liver dysfunction 11.Patients with disease of blood or hematopoietic organs (hemoglobin 10 g/dL) 12.Patients with G6PD deficiency. 13.Patients with proliferative diabetic retinopathy or those with retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology. 14.Patients with known history of HIV 1 or HIV 2, Hepatitis B or C Viruses or syphilis infection. 15.Patients with known history of hypersensitivity to study drugs 16.Patients with history of drug dependence, other substance abuse or excessive alcohol intake on habitual basis 17.Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment. 18.Pregnant or lactating women. 19.Women of childbearing potential not practicing contraception. Method of Generating Computer generated randomization Random Sequence Method of Pre-numbered or coded identical Containers Concealment Blinding/Masking Double Blind Double Dummy Primary Outcome Outcome Timepoints 1.To assess the change from baseline in At the end of 24 weeks and 52 weeks. estimated glomerular filtration rate (eGFR) with hydroxychloroquine as an add on therapy as compared with placebo. Secondary Outcome Outcome Timepoints 1. Proportion of patients reporting fall in eGFR week 52 2.Change in eGFR 4 weeks after last
page 7 / 8 PDF of Trial CTRI Website URL - http://ctri.nic.in
adminstration of study drug 4. Incidence of primary non-fatal cardiovascular events 5. Cardiovascular mortality 6.Need for ESA or change in dose of ESA 7. To Compare safety and tolerability 8.Change in Urine albumin to creatinine ratio,HbA1c, BUN, Sr. Creatinine,Uric acid serum potassium, hemoglobin,lipid profile,HsCRP Target Sample Size Total Sample Size=308 Sample Size from India=308 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 2 Date of First 02/02/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Other (Terminated) Trial (India) Publication Details Brief Summary The primary purpose of conducting this study is to evaluate the role of hydroxychloroquine in preservig the kidney function by slowing down the progression of knidney diseasedue to type-II diabetes. Considering the multifaceted effects of hydroxychloroquine and corresponding pathophysiological mechanisms involved in diabetic nephropathy, we propose that concurrent use of hydroxychloroquine along with ACE inhibitor or ARB or their combination with other antihypertensive agents may slow down the progression of chronic kidney disease in type-II diabetic patients.
page 8 / 8
Powered by TCPDF (www.tcpdf.org)