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CTRI Number  CTRI/2012/06/002743 [Registered on: 25/06/2012] Trial Registered Retrospectively
Last Modified On: 13/06/2012
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A clinical study to establish a database for evaluation of disease progression in adults patients with chronic kidney disease 
Scientific Title of Study   A prospective, multi-centre, observational study to establish database to evaluate the disease progression in adults with chronic kidney disease 
Secondary IDs if Any  
Secondary ID  Registry 
HNL/FKCKDOD/01/10   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Sadanand Kulkarni 
Address  5th Floor, A-Wing, Ashoka Plaza, Pune-Nagar Road, Survey No. 32/2, Wadgaon Sheri,Viman Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone    
Fax    
Email  sadanand.kulkarni@fresenius-kabi.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Umesh Gupta 
Address  5th Floor, A-Wing, Ashoka Plaza, Pune-Nagar Road, Survey No. 32/2, Wadgaon Sheri,Viman Nagar, Pune

Pune
MAHARASHTRA
411014
India 
Phone    
Fax    
Email  umesh.gupta@fresenius-kabi.com  
 
Source of Monetary or Material Support  
Fresenius Kabi Asia Pacific Ltd. 
 
Primary Sponsor  
Name  Fresenius Kabi Asia Pacific Ltd 
Address  Rm 5003-36, 50/F, Sun Hung Kai Centre 30 Harbour Road, Wanchai, Hong Kong  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Thailand  
Sites of Study
Modification(s)  
No of Sites = 6  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Shah  Anil Clinic  Anil Clinic, B-4, Shilpa Apartments, Doctor Charatsinghcolony, Near RBI Quarters, AG Link Road, Chakala, Andheri East
Mumbai
 
91-22-28368364

anilclinic@hotmail.com 
Dr Sham Sunder  Dr. Ram Manohar Lohiya hospital  Department of Nephrology, Dr. Ram Manohar Lohiya Hospital, Near Goldaak Khana, Baba Kharak Singh Marg
New Delhi
 
91-11-23741640

shamsunderrml@rediffmail.com 
Dr Ashwani Gupta  Intermed Superspeciality Clinic  38/16, Patel Nagar
New Delhi
 
91-11-25853400

ashwani_gupta2002@yahoo.com 
Dr Ashok Kirpalani  Kidney and blood pressure clinic  Kidney and Blood Pressure CLinic, 108, Lady Ratatan Tata Medical and Research center, Maharshi Karve Marg, Cooperage
Mumbai
 
91-22-852013

dkirpalani@hotmail.com 
Dr Umesh Khanna  Lancelot Hospital  Lancelot hospital, SV Road, Borivali (West)
Mumbai
 
91-22-28012783

mu_khanna@yahoo.co.in 
Dr Deodatta S Chafekar  Supreme Kidney Care  Supreme Kidney Care, Om chambers, Sadhu Vaswani Road, Opp. Holaram colony, Near MICO circle
Nashik
 
91-253-2313688

nchafy@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
Institutional Ethics Committee, Dr. Ram Manohar Lohia Hospital  Approved 
Lancelot Independent Ethics Committee, Mumbai; Applicable PIs - Dr. Ashok Kirpalani, Dr. Bharat Shah, and Dr. Umesh Khanna  Approved 
Shatabdi Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Kidney Disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male and female patients with age ≥ 18 years and regularly attending a given site
2.Patients with CKD (glomerular filtration rate (GFR) < 90 ml/min per 1.73 m2) stages 2 and below (stage 2 to 5)
3.Patients with life expectancy of at least 6 months
4.Patients who are willing and able to adhere to the protocol requirements 
 
ExclusionCriteria 
Details  1.Patients who have undergone kidney transplant
2.Patients who have a sustained sitting systolic blood pressure (BP) more than 160 mmHg or sustained sitting diastolic BP more than 110 mmHg
3.Patients with an independently co-existing life-threatening disease, such as cancer
4.Patients who have undergone previous carotid artery surgery and/or a carotid artery stenosis greater than 75% at baseline.
5.Patients with history of co-morbidities that in the investigator’s opinion would interfere with the study participation and impact life expectancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical course and therapy sequences of the Chronic Kidney Disease (CKD)   Death or day of surgery for renal transplant or lost to follow-up  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events, mortality, co-morbidities  Death or day of surgery for renal transplant or lost to follow-up  
 
Target Sample Size   Total Sample Size="2500"
Sample Size from India="2000" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
20/07/2011 
Date of First Enrollment (Global)  20/07/2011 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   This study is a prospective, multi-centre, observational study establishing database to evaluate the disease progression in adults with chronic kidney disease (CKD) that will be conducted in 5-10 centers and 1-3 centers in other Asian country(ies). This study aims to generate a database of CKD patient population in order collect data on management strategies and survival, with an objective to optimize the medical and interventional treatment strategies in prevention and therapy. Primary outcome measure will be clinical course and therapy sequences of the CKD patients till death or day of surgery for renal transplant or lost to follow-up. Secondary outcome measures will be Incidence of adverse events, mortality, and co-morbidities. 

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