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 |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
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Address |
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Phone |
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Fax |
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Email |
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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 |
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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 |
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Source of Monetary or Material Support
|
Fresenius Kabi Asia Pacific Ltd. |
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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 |
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Details of Secondary Sponsor
|
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Chronic Kidney Disease |
|
Intervention / Comparator Agent
|
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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 |
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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 |
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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 |
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Secondary Outcome
|
Outcome |
TimePoints |
Adverse events, mortality, co-morbidities |
Death or day of surgery for renal transplant or lost to follow-up |
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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
|
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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. |