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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.
Timepoint [1] 0 0
Up to 4.6 years
Secondary outcome [1] 0 0
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF) - The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.
Timepoint [1] 0 0
Up to 4.6 years
Secondary outcome [2] 0 0
Major Adverse Cardiac Event (MACE) - The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Timepoint [2] 0 0
Up to 4.6 years
Secondary outcome [3] 0 0
Hospitalized Heart Failure (HHF) - Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.
Timepoint [3] 0 0
Up to 4.6 years
Secondary outcome [4] 0 0
Renal Composite Endpoint - The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
Timepoint [4] 0 0
Up to 4.6 years
Secondary outcome [5] 0 0
Cardiovascular (CV) Death - CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.
Timepoint [5] 0 0
Up to 4.6 years
Secondary outcome [6] 0 0
All-cause Mortality - Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.
Timepoint [6] 0 0
Up to 4.6 years
Secondary outcome [7] 0 0
CV Composite Endpoint - The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.
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
Gender
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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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
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).
Trial website
https://clinicaltrials.gov/show/NCT02065791
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