| CTRI Number |
CTRI/2010/091/000349 [Registered on: 21/01/2011] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the clinical effects on safety and efficacy of Kremezin® on suppression of progression of Chronic Renal Failure. |
Scientific Title of Study
Modification(s)
|
A randomized, multicentre, parallel, open label, active controlled, phase III study to evaluate the clinical efficacy and safety of Kremezin® on suppression of Progression of Chronic Renal Failure |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| KR-09-03 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
|
| Affiliation |
|
| Address |
LG House, Plot no 11
Sector 44
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
deepali.mittal@lglsi.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
|
| Affiliation |
Project Leader |
| Address |
LG House, Plot no 11
Sector 44
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
deepali.mittal@lglsi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
|
| Affiliation |
Project Leader |
| Address |
LG House, Plot no 11
Sector 44
Gurgaon
HARYANA
122 001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
deepali.mittal@lglsi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| LG Life Sciences India Pvt Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
LG Life Sciences India Pvt Ltd |
| Address |
Plot no 11, Sector 44, Gurgaon 122001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Pradeep Salgia |
9/5, Manoramaganj, |
Opp St.Paul Primary School,,-452001
Indore
MADHYA PRADESH |
0731-2528090
psalgia@sancharnet.in |
| Dr Deepak Dewan |
Ajanta Research Centre |
Ajanta Research Centre, Ajanta Hospital and IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow 226005
Lucknow
UTTAR PRADESH |
91522401139
91522410101
drdeepakdewan@rediffmail.com |
| Dr. Sanjay Agarwal |
All India Institute of Medical Sciences, |
Ansari Nagar,,-110029
New Delhi
DELHI |
011-26593292/26594911
skagarwal58@yahoo.co.in |
| Dr. Soma Sekhar |
Apollo hospitals |
jubilee Hills,-500 033
Hyderabad
ANDHRA PRADESH |
09391384659
hyd@aherf.smo.org |
| Dr. Rajesh Bharani |
Bombay Hospital |
Ring Road,-452010
Indore
MADHYA PRADESH |
9826082202
rajeshbharani@yahoo.co.in |
| Dr. Ashwini Kumar Khandekar |
Care Hospital, |
3, Farmland,,Panchsheel Square, Ramdaspeth-440010
Nagpur
MAHARASHTRA |
0712-3012021, 3012022, 3012023
aakhandekar@gmail.com |
| Dr. Rubina Vora |
CHL Apollo Hospitals |
A.B. Road, ,Near L.I.G. Triangle-452008
Indore
MADHYA PRADESH |
0731 4072550
rubina.vohra@gmail.com |
| Dr. Sundar |
Columbia Asia Referral Hospital Yeshwantpur |
Next to Metro,malleswaram West-560055
Bangalore
KARNATAKA |
080-29898969
ssundar99@hotmail.com |
| Dr. Dinesh Jain |
Dayanand Medical College & Hospital |
New tagore nagar,Civil lines-1441001
Ludhiana
PUNJAB |
0161-2303263, 5024533
drjaindinesh@yahoo.co.in |
| Dr. Sandeep Kumar Gupta |
M.V. Hospital & Research Centre |
314/30,Mirza Mandi Chowk-226003
Lucknow
UTTAR PRADESH |
09415026054
sandeepkumar.gupta@rediffmail.com |
| Dr. Bhushan Raju |
Nizam's Institute of Medical Sciences |
Panjagutta,-500082
Hyderabad
ANDHRA PRADESH |
09848492951
sreebhushan@hotmail.com |
| Dr. Ravi Bansal |
Pushpawati Singhania Research Institute, |
Sheikh Sarai-II,,-110017
New Delhi
DELHI |
011- 30611700
dr_ravibansal@yahoo.com |
| Dr. Narayan Prasad |
sanjaya Gandhi Post Graduate Institute of medical Sciences |
Dept of Nephrology,Raebarelli Road-226014
Lucknow
UTTAR PRADESH |
0522-2668004-2668008
narayan@sgpgi.ac.in |
| Dr. Alok Jain |
SEAROC Cancer Centre |
S K Sony Hospital, Sector - 5,Vidhyadhar Nagar-302013
Jaipur
RAJASTHAN |
9829696995
drjainalok@gmail.com |
| Dr. J B Gupta |
SR Kalla Memorial Hospital, |
78, Dhuleshwar Garden,,Behind HSBC Bank, Sardar Patel Marg, C Scheme,-302001
Jaipur
RAJASTHAN |
09829414680
drjbgupta@gmail.com |
| Dr. Gokulnath |
St. John Medical College & Hospital |
Sarjapur Road,-560034
Bangalore
KARNATAKA |
080-22065301
gokul_neph@yahoo.co.uk; sjmch_nephro@yahoo.com.ph |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Bioethics Forum of Lucknow |
Approved |
| Ethics Committee, Apollo Hospitals, (Apollo Health City), Jubilee Hills, Hyderabad- 500096 |
Approved |
| Institutional Ethical Review Board, Ground Floor, St. Johns Medical College, Sarjapur Road, Bangalore- 560034 |
Approved |
| Institutional Ethics Commitee, Columbia Asia Hospitals, Columbia Asia Referral Hospital- Yeshwanthpur, #26/1, Brigade Gateway, Beside Metro, Malleshwaram, West, Bangalore- 560055 |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
Approved |
| Institutional Ethics Committee, Bombay Hospital, Ring Road Indore-452010 |
Approved |
| Institutional Ethics Committee, care Hospital, Hyderabad |
Approved |
| Institutional Ethics Committee, CHL Apollo Hospitals, A.B Road, Near L.I.G Triangle, Indore-452008. |
Approved |
| Institutional Ethics Committee, Dayanand Medical College & Hospital, New Tagore Nagar. Civil Lines, Ludhiana-141001 Ludhiana |
Approved |
| Institutional Ethics Committee, M.V. Hospital & Research Centre, 314/30, Mirza Mandi Chowk, Lucknow, UP- 226003 |
Approved |
| Institutional Ethics Committee, Nizams Institute of Medical Sciences, Hyderabad |
Approved |
| Institutional Ethics Committee, Pushpawati Singhania Research Institute, Sheikh Sarai-II,New Delhi-17 |
Approved |
| Institutional Ethics Committee, Sanjaya Gandhi Post Graduate Institute of Medical Sciences, Dept. of Nephrology, Raebareli Road, Lucknow-226014, UP |
Approved |
| SEAROC Ethics Committee, SEAROC Cancer Centre, S K Sony Hospital, Sector-5, Vidhyadhar Nagar, Jaipur- 302013 |
Approved |
| SR Kalla Memorial Ethics Committee for Human research, 78, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C Scheme, Jaipur- 302001 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Kidney Disease stage 3 and 4, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Kremezin(study drug) |
Dose-3 sachets (2 gm/each)per day. Duration: 12 months |
| Comparator Agent |
Standard-of-care therapy (conservative treatment) |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A. Outpatients only of either sex of 18-70 years
B. CKD Stage 3, 4 (GFR by Cockcroft Gault equation 15-59 mL/min 1.73M2)
C. Blood pressure that is well controlled during the observation period
D. Willing and able to give informed consent and comply with study procedures. |
|
| ExclusionCriteria |
| Details |
1. Received any investigational agent or participated in a clinical study with the previous 2 months
2. History of gastrointestinal disease (active gastric ulcer, inflammatory bowel diseases,hiatal hernia, active peptic ulcer, or severe GI dysmotility)
3. Obstructive urologic disease and other reversible kidney
diseases
4. Chronic kidney disease due to autosomal dominant polycystic kidney disease
5. Severe nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine (both components measured as mg/dl or other like units) of > 6.0 as measured on a spot void.
6. History of previous kidney transplant
7. History of recent (within the past 1 month) accelerated
or malignant hypertension
8. Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months
9. Liver cirrhosis
10. Patients with active infection, uncontrolled inflammatory disease
11. Progressive malignant disease
12. Cerebral infarction and intracranial hemorrhage within 6 months , except transient ischemic attack (TIA)
13. Uncontrolled blood sugar (HbA1c > 9%)
14. Severe anaemia, Hb <7 g/dL
15. ALT or AST > 2.5 times the upper limit of normal
Life expectancy less than 12 months at the point of Randomization
16. Received immunosuppressive therapy (including systemic
corticosteroids for more than 5days at a daily dose in excess of 0.1 mg/kg, prednisolone equivalent) in the past 3 months, or anticipated to require such treatment during the study course.Pregnant patients and willing to bear child during study. 17. Patient with marked changes in diseases status such as cases with abnormally high levels of blood pressure (diastolic pressure 120 mm Hg or over) or unstable levels,
18. Patients judged as inadequate subjects for the study by investigators such as those with markedly poor self-management. |
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement rating of the change of 1/ Cr (creatinine) with time in the two groups. The improvement ratings will be determined the ratio of greater than 1 as improved, the ratio equal to 1 as unchanged and the ratio lesser than 1 as aggravated. |
Observation period (-24 weeks) to treatment period (48 weeks) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups, according to the 3 - Grade criteria viz. Improved, Unchanged and Aggravated |
48 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="232"
Sample Size from India="232"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This clinical study is a randomised, parallel,active controlled, open label,phase III multicenter trial evaluating the safety and efficacy of Kremezin® upon administration of 6gm/ day alongwith the standard care of therapy for 48 weeks on 232 subjects with progression of chronic kidney disease of stage 3 and 4.The primary outcome measures Improvement rating of the change of 1/ Cr (creatinine) with time period from screenng to the end of treatment schedule in the two groups. The improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups,from the period of screening to end of treatment schedule, according to the 3 - Grade criteria viz. Improved, Unchanged and Aggravated. |