| CTRI Number |
CTRI/2015/12/006420 [Registered on: 07/12/2015] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of the Effects of Canagliflozin
on Renal and Cardiovascular Outcomes in
Participants with Diabetic Nephropathy |
|
Scientific Title of Study
|
A Randomized, Double-blind, Eventdriven,
Placebo-controlled, Multicenter
Study of the Effects of Canagliflozin on
Renal and Cardiovascular Outcomes in
Subjects With Type 2 Diabetes Mellitus
and Diabetic Nephropathy |
| Trial Acronym |
CREDENCE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2013-004494-28 |
EudraCT |
| 28431754DNE3001 Amendment INT-2 dated 03 Feb 2015 |
Protocol Number |
| NCT02065791 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra R Dixit |
| Designation |
Head Global Clinical Operations India |
| Affiliation |
Johnson and Johnson Private Limited |
| Address |
Correspondence address: Global Clinical Operations
Johnson and Johnson Private Limited
Arena Space
Behind Majas Bus Depot
Off JVLink Road
Jogeshwari East
Registered address: Johnson and Johnson Private Limited
LBS Marg
Mulund West
Mumbai 400080
Mumbai
MAHARASHTRA
400060
India
Mumbai
MAHARASHTRA
400060
India |
| Phone |
9167068006 |
| Fax |
|
| Email |
jdixit@its.jnj.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra R Dixit |
| Designation |
Head Global Clinical Operations India |
| Affiliation |
Johnson and Johnson Private Limited |
| Address |
Correspondence address: Global Clinical Operations
Johnson and Johnson Private Limited
Arena Space
Behind Majas Bus Depot
Off JVLink Road
Jogeshwari East
Registered address: Johnson and Johnson Private Limited
LBS Marg
Mulund West
Mumbai 400080
Mumbai
MAHARASHTRA
400060
India
Mumbai
MAHARASHTRA
400060
India |
| Phone |
9167068006 |
| Fax |
|
| Email |
jdixit@its.jnj.com |
|
|
Source of Monetary or Material Support
|
| Janssen Research Development LLC |
|
|
Primary Sponsor
|
| Name |
Janssen Research Development LLC |
| Address |
920 Route 202 South, Raritan New Jersey 08869, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Johnson and Johnson Private Limited |
LBS Marg
Mulund West
Mumbai 400080 |
|
|
Countries of Recruitment
|
Argentina
Australia
Bulgaria
Chile
China
Colombia
Czech Republic
Egypt
France
Germany
Guatemala
Hungary
India
Italy
Japan
Lithuania
Malaysia
Mexico
New Zealand
Philippines
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
South Africa
Taiwan
Ukraine
United Kingdom
United States of America
Serbia
Spain
Brazil
Canada |
Sites of Study
Modification(s)
|
| No of Sites = 22 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Deewan |
Ajanta Research Centre |
Ajanta Research Centre, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH |
9936507362
drdeepakdewan@rediffmail.com |
| Dr Sreelatha Melemadathil |
Calicut Govt Medical College |
Calicut Govt Medical College, Kozhikode, Kerala
Kozhikode
KERALA |
9446338109
researchatcmc@gmail.com |
| Dr Dinesh Jain |
DMC Hospital |
DMC Hospital, Ludhiana, Punjab
Ludhiana
PUNJAB |
9815532533
drjaindinesh@yahoo.co.in |
| Dr Noble Gracious |
Government Medical College, Trivandrum |
Government Medical College, Dept. of Nephrology, Ullor Road, Trivandrum 695011
Thiruvananthapuram
KERALA |
04712528658
04712528658
noblegracious@hotmail.com |
| Dr Dhananjay Kumar Sinha |
Heritage Hospital Ltd |
Heritage Hospital Ltd, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
9415304564
dksinha15@gmail.com |
| Dr Satish Balan |
Kerala Institute of Medical Sciences (KIMS) |
Kerala Institute of Medical Sciences (KIMS), Trivendrum, Kerala
Thiruvananthapuram
KERALA |
4713041406
balansatish@rediffmail.com |
| Dr Ramesh Chandra Vyasam |
King George Hospital |
King George Hospital, Vishakapatnam, Andra Pradesh
Visakhapatnam
ANDHRA PRADESH |
9440147781
rameshchandravyasam@gmail.com |
| Dr Sreedhar Reddy |
Krishna Institute of Medical Sciences |
Krishna Institute of Medical Sciences, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH |
9866671019
shridhareddy@gmail.com |
| Dr Natarajan Gopalakrishnan |
Madras Medical College and Government General Hospital |
Madras Medical College and Government General Hospital, Chennai, Tamilnadu
Chennai
TAMIL NADU |
9444085404
srigola751@yahoo.com |
| Dr Dinesh Khullar |
Max Healthcare Super Speciality Hospital |
Max Healthcare Super Speciality Hospital, Delhi, Delhi
Central
DELHI |
9810124066
drdineshkhullar@gmail.com |
| Dr Manju Thampi |
NIMS Medicity |
NIMS Medicity, Trivandrum, Kerala
Thiruvananthapuram
KERALA |
8891000510
nims.research@gmail.com |
| Dr Sree Bhushan Raju |
Nizams Institute of Medical Sciences |
Nizams Institute of Medical Sciences, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH |
9848492951
sreebhushan@hotmail.com |
| Dr Manisha Sahay |
Osmania General Hospital |
Osmania General Hospital, Hyderabad, Telangana
Hyderabad
ANDHRA PRADESH |
9849097507
dksinha15@gmail.com |
| Dr Alan Fernandes Almeida |
P. D. Hinduja National Hospital and Research Center |
P. D. Hinduja National Hospital and Research Center, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
9619726888
almeidaa@gmail.com |
| Dr Jayameena Peringat |
PVS Hospital (P) Ltd |
PVS Hospital (P) Ltd, Calicut, Kerala
Kozhikode
KERALA |
9745819471
pvscalicut.cr@gmail.com |
| Dr Abraham Oomman |
Ramana Maharshi Rangammal Hospital |
Ramana Maharshi Rangammal Hospital, Athivandal Tiruvannmalai, Tamilnadu
Tiruvanamalai
TAMIL NADU |
9841174578
rmrh007@gmail.com |
| Dr Dhananjai Agarwal |
S. M. S. Medical College and Hospital |
S. M. S. Medical College and Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9414459790
drdhananjainephro@yahoo.co.in |
| Dr Narayan Prasad |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH |
9415403140
narayan.nephro@gmail.com |
| Dr B Sudhakar |
St. Theresas Hospital |
St. Theresa’s Hospital, Sanathnagar, Hyderabad, Telangana - 500018
Hyderabad
ANDHRA PRADESH |
04023704411
04023814556
drbsudhakar@yahoo.com |
| Dr M Edwin Fernando |
Stanley Medical College |
Stanley Medical College, Chennai, Tamil Nadu
Chennai
TAMIL NADU |
9841018717
nephroeddy@gmail.com |
| Dr Keshavamurthy C B |
Vikram Hospital Private Limited |
Vikram Hospital Private Limited
No. 46, Vivekananda Road, Yadavagiri, Mysore - 570020
Mysore
KARNATAKA |
9341052852
cbkeshavamurthy@gmail.com |
| Dr Hansraj Alva |
Vinaya Hospital and Research Center |
Vinaya Hospital and Research Center, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA |
9343562622
hansalva2001@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 22 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital, Ludhiana |
Approved |
| Ethics Committee Heritage Hospital Varanasi |
Approved |
| Ethics Committee Maharishi Rangammal hospital |
Approved |
| Ethics Committee SMS Medical College Jaipur |
Approved |
| Ethics Committee, St. Theresas Hospital, Hyderabad |
Approved |
| Government Medical College Kozhikode Institutional Research Committee |
Approved |
| Institute Ethics Committee , SGPGI, Lucknow |
Approved |
| Institutional Ethics Committee for Ajanta Hospital and IVF centre |
Approved |
| Institutional Ethics Committee Madras Medical College |
Approved |
| Institutional Ethics Committee PVS (P) Hospital Limited, Calicut |
Approved |
| Institutional ethics Committee, Noorul Islam Institute of Medical Sciences(NIMS) & Research Foundation, NIMS, Trivandrum |
Not Applicable |
| Institutional Ethics Committee, P.D. Hinduja National Hospital & Medical Research Centre, Mumbai |
Approved |
| Institutional Ethics Committee, Stanley Medical College, Chennai |
Approved |
| Institutional Ethics Committee,Max Healthcare Super Speciality Hospital,Delhi |
Approved |
| Institutional Human Ethics Committee, KIMS, Kerala |
Approved |
| Instiutional Ethics Committee Situated at M/s. King George Hospital, Vishakhapatnam |
Approved |
| KFRC Ethics Committee KIMS Foundation & Research Center, Telangana |
Approved |
| NIZAMS Institutional Ethics Committee, Hyderabad |
Approved |
| Omega Ethics Committe Omega Hospital |
Approved |
| Osmania Medical College Ethics Committee |
Approved |
| The Human Ethics Committee, Government Medical College, Trivandrum |
Approved |
| Vikram Hospital Ethics Committee (VHEC) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus (T2DM) with Diabetic Nephropathy, (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cangliflozin |
100 mg once daily orally before the first meal of the day for up to 5.5 years (66 months) or longer |
| Comparator Agent |
Placebo |
once daily orally before the first meal of the day for up to 5.5 years (66 months) or longer |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects 30 years and older with Type 2 diabetes mellitus with a hemoglobin A1c HbA1c greater than or equal to 6.5 percent and less than or equal to 12 percent with an estimated glomerular filtration rate eGFR of greater than or equal to 30 milliliter mL per minute per 1.73 meter and less than 90 milliliter mL per minute (min)/1.73meter Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin
receptor blocker (ARB) for at least 4 weeks prior to randomization - Must have a urine albumin to creatinine ratio UACR of greater than 300 milligram mg per g and less than or equal to 5000 mg per g |
|
| ExclusionCriteria |
| Details |
History of diabetic ketoacidosis or type 1 diabetes mellitus - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Renal disease that required treatment with immunosuppressive therapy - Known significant liver disease - Current or history of New York Heart Association (NYHA) Class IV heart failure - Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to the first occurrence of an
event in the primary composite
endpoint.
The primary composite endpoint of the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular
(CV) death. |
Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ]
endpoint]. The primary composite endpoint of
the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to the first occurrence of an
event in the CV composite endpoint. The CV composite endpoint includes
CV death, non-fatal myocardial
infarction (MI), non-fatal stroke,
hospitalized congestive heart failure
and hospitalized unstable angina. |
Baseline, up to approximately Month
66 |
Time to the first occurrence of an
event in the renal composite endpoint. The renal composite endpoint
includes ESKD, doubling of serum
creatinine, and renal death. |
Baseline, up to approximately Month
66 |
Time to all-cause death. All deaths occurring during the study
from any cause. |
Baseline, up to approximately Month
66 |
|
|
Target Sample Size
|
Total Sample Size="3700"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
14/12/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/02/2014 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB). |