Trial document

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This study has been imported from ClinicalTrials.gov without additional data checks.

drksid header

DRKS-ID: DRKS00006386

Trial Description

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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

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Trial Acronym

CREDENCE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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.

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Organizational Data

DRKS-ID: DRKS00006386
Date of Registration in DRKS: 2014/11/17
Date of Registration in Partner Registry or other Primary Registry: 2014/02/17
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2013-004494-28
Primary Registry-ID: NCT02065791 (ClinicalTrials.gov)
Sponsor-ID: CR103517 (Janssen Research & Development, LLC)
Other Secondary-ID: 2013-004494-28
Other Secondary-ID: 28431754DNE3001

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Health Condition or Problem studied

Free text: Diabetes Mellitus, Type 2
Free text: Diabetic Nephropathies
ICD10: E11.2 - Non-insulin-dependent diabetes mellitus; With renal complications
ICD10: N08.3 - Glomerular disorders in diabetes mellitus

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Interventions/Observational Groups

Arm 1: Drug: Canagliflozin
Arm 2: Drug: Placebo

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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Primary Outcome

- Time to the first occurrence of an event in the primary composite endpoint; time frame: Baseline, up to Month 66; The primary composite endpoint of the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.

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Secondary Outcome

- Time to the first occurrence of an event in the CV composite endpoint; time frame: Baseline, up to 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.
- Time to the first occurrence of an event in the renal composite endpoint; time frame: Baseline, up to Month 66; 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; All deaths occurring during the study from any cause.

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Countries of Recruitment

US: United States
AR: Argentina
AU: Australia
BG: Bulgaria
CA: Canada
CZ: Czech Republic
DE: Germany
HK: Hong Kong
HU: Hungary
KR: Korea, Republic of
MY: Malaysia
MX: Mexico
NZ: New Zealand
PH: Philippines
PL: Poland
RO: Romania
RU: Russian Federation
ZA: South Africa
ES: Spain
UA: Ukraine
UK: United Kingdom

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Locations of Recruitment

Bad Kreuznach - Bosenheim
Berlin, Be
Dietzenbach
Dresden
Essen
Goch
Hamburg
Hannover
Muenster
Wangen

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2014/02/27
Target Sample Size: 3700
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 30 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

- Type 2 diabetes mellitus with an HbA1c >= 6.5% and <=10.5%, with an estimated
glomerular filtration rate (eGFR) of >= 30 and < 90 mL/min/1.73m2

- Participants need to be on a 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 > 300 mg/g and <= 5000 mg/g

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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

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Addresses

Primary Sponsor
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- Janssen Research & Development, LLC
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- The George Institute for Global Health, Australia
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Janssen Research & Development, LLC
- Janssen Research & Development, LLC Clinical Trial
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
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- Telephone: [---]*
- Fax: [---]*
- E-mail: JNJ.CT at sylogent.com
- URL: [---]*
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Sources of Monetary or Material Support

[---]*
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Further trial documents: To learn how to participate in this trial please click here.

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .

Translation on version: 2
Last processed date by ClinicalTrials.gov: 2014/12/02

* This entry means the parameter is not applicable or has not been set.