Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE)
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).
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official 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|
- Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to Month 66 ] [ Designated as safety issue: Yes ]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 CV composite endpoint [ Time Frame: Baseline, up to Month 66 ] [ Designated as safety issue: Yes ]The CV composite endpoint includes CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalized congestive heart failure and hospitalized unstable angina.
- Time to the first occurrence of an event in the renal composite endpoint [ Time Frame: Baseline, up to Month 66 ] [ Designated as safety issue: Yes ]The renal composite endpoint includes ESKD, doubling of serum creatinine, and renal death.
- Time to all-cause death [ Time Frame: Baseline, up to Month 66 ] [ Designated as safety issue: Yes ]All deaths occurring during the study from any cause.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||November 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily
One 100 mg over-encapsulated tablet orally once daily
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily
One matching placebo capsule orally (by mouth) once daily
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin on renal and cardiovascular outcomes in participants with type 2 diabetes mellitus (T2DM) and diabetic nephropathy, who are receiving standard of care including a maximum tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
The study will consist of a pretreatment phase (several weeks), and a double-blind treatment phase (up to 66 months). During the pretreatment phase all participants will also receive diet/exercise counseling for lipid and blood pressure management as well as counseling on renal and cardiovascular (CV) risk factor medication. A post-treatment follow-up contact or visit will take place approximately 30 days after the last dose of study drug or the completion of the study. The total duration of the study is estimated to be about 5.5 years. Approximately 3,700 participants will be randomized in a 1:1 ratio to canagliflozin or matching placebo. Participants randomized to canagliflozin will receive a dose of 100 mg once daily. The overall safety and tolerability of canagliflozin will be evaluated by collecting information on adverse events, laboratory tests, vital signs (pulse, blood pressure), physical examination, and body weight.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02065791
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|