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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02065791




Registration number
NCT02065791
Ethics application status
Date submitted
17/02/2014
Date registered
19/02/2014
Date last updated
5/12/2019

Titles & IDs
Public title
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Scientific title
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
Secondary ID [1] 0 0
2013-004494-28
Secondary ID [2] 0 0
CR103517
Universal Trial Number (UTN)
Trial acronym
CREDENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Diabetic Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin
Treatment: Drugs - Placebo

Experimental: Canagliflozin 100 mg - Each participant will receive 100 mg of canagliflozin once daily

Placebo comparator: Placebo - Each participant will receive matching placebo once daily


Treatment: Drugs: Canagliflozin
One 100 mg over-encapsulated tablet orally once daily

Treatment: Drugs: Placebo
One matching placebo capsule orally (by mouth) once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death
Timepoint [1] 0 0
Up to 4.6 years
Secondary outcome [1] 0 0
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
Timepoint [1] 0 0
Up to 4.6 years
Secondary outcome [2] 0 0
Major Adverse Cardiac Event (MACE)
Timepoint [2] 0 0
Up to 4.6 years
Secondary outcome [3] 0 0
Hospitalized Heart Failure (HHF)
Timepoint [3] 0 0
Up to 4.6 years
Secondary outcome [4] 0 0
Renal Composite Endpoint
Timepoint [4] 0 0
Up to 4.6 years
Secondary outcome [5] 0 0
Cardiovascular (CV) Death
Timepoint [5] 0 0
Up to 4.6 years
Secondary outcome [6] 0 0
All-cause Mortality
Timepoint [6] 0 0
Up to 4.6 years
Secondary outcome [7] 0 0
CV Composite Endpoint
Timepoint [7] 0 0
Up to 4.6 years

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than (<) 90 mL/min/1.73 m^2
* 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)/gram (g) and <= 5000 mg/g
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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- Cairns
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- Concord
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- Darlinghurst
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- Elizabeth Vale
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- Fremantle
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- Gosford
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- Heidelberg
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- Keswick
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- Parkville
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- Reservoir
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- Richmond
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- St Leonards
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- Sydney
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Romania
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Ufa
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Volgograd
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Russian Federation
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute for Global Health, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.