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Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02065791
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetic Nephropathy Drug: Canagliflozin Drug: Placebo Phase 3

Detailed Description:

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 approximately 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 to 5.5 years. Approximately 4,200 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : February 17, 2014
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily
Drug: Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily
Drug: Placebo
One matching placebo capsule orally (by mouth) once daily



Primary Outcome Measures :
  1. Time to the First Occurrence of an Event in the Primary Composite Endpoint [ Time Frame: Baseline, up to approximately Month 66 ]
    The primary composite endpoint of the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.


Secondary Outcome Measures :
  1. Time to the First Occurrence of an Event in the Composite Endpoint of CV Death and Hospitalized Congestive Heart Failure [ Time Frame: Baseline, up to approximately Month 66 ]
    The composite endpoint includes CV death and hospitalized congestive heart failure. The CV death is death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, presumed sudden CV death, death of unknown cause, or death resulting from a documented CV cause other than those listed above (eg, aneurysm, peripheral vascular disease [PVD]).

  2. Time to the First Occurrence of an Event in the Composite Endpoint of CV death, Non-fatal MI, and Non-fatal Stroke (that is, 3-Point Major Adverse Cardiac Event [MACE]) [ Time Frame: Baseline, up to approximately Month 66 ]
    The composite endpoint includes CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE).

  3. Time to the First Occurrence of Hospitalized Congestive Heart Failure [ Time Frame: Baseline, up to approximately Month 66 ]
    Time to the First Occurrence of Hospitalized Congestive Heart Failure will be assessed.

  4. Time to the First Occurrence of an Event in the Renal Composite Endpoint [ Time Frame: Baseline, up to approximately Month 66 ]
    The renal composite endpoint includes ESKD, doubling of serum creatinine, and renal death.

  5. Time to CV Death [ Time Frame: Baseline, up to approximately Month 66 ]
    The CV death is death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure related complications, presumed sudden CV death, death of unknown cause, or death resulting from a documented CV cause other than those listed above (for example, aneurysm, PVD).

  6. Time to All-cause Death [ Time Frame: Baseline, up to approximately Month 66 ]
    All deaths occurring during the study from any cause.

  7. Time to the First Occurrence of an Event in the CV Composite Endpoint [ Time Frame: Baseline, up to approximately Month 66 ]
    The CV composite endpoint includes CV death, non-fatal myocardial infarction (MI), non- fatal stroke, hospitalized congestive heart failure and hospitalized unstable angina.



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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065791


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Taipei, Taiwan
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Kharkiv, Ukraine
Kiev, Ukraine
Kyiv, Ukraine
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Birmingham, United Kingdom
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Bolton, United Kingdom
Bournemouth, United Kingdom
Bradford, United Kingdom
Bristol, United Kingdom
Burbage, United Kingdom
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Cardiff, United Kingdom
Carlshalton, United Kingdom
Carmarthen, United Kingdom
Chester, United Kingdom
Darlington, United Kingdom
Doncaster, United Kingdom
Durham, United Kingdom
Ely, United Kingdom
Hampstead, United Kingdom
Harlow, United Kingdom
Huntingdon, United Kingdom
Leamington Spa, United Kingdom
Liskeard, United Kingdom
London, United Kingdom
Middlesbrough, United Kingdom
Plymouth, United Kingdom
Rhyl, United Kingdom
Rugby, United Kingdom
Salford, United Kingdom
Stoke On Trent, United Kingdom
Swansea, United Kingdom
Torpoint, United Kingdom
Watford, United Kingdom
Welwyn Garden City, United Kingdom
Westcliff On Sea, United Kingdom
Wokingham, United Kingdom
Wolverhampton, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02065791     History of Changes
Other Study ID Numbers: CR103517
2013-004494-28 ( EudraCT Number )
28431754DNE3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Canagliflozin
JNJ-28431754
End-Stage Kidney Disease
Chronic Kidney Disease
Macroalbuminuria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs