Trial · NCT02065791

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

NCT02065791, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2019-11-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy. Trials, record NCT02065791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02065791

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
NCT number: NCT02065791
Status: Completed
Phases: Phase 3
Enrollment: 4,401 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Diabetes Mellitus, Type 2, Diabetic Nephropathy
Interventions: Canagliflozin, Placebo
First posted: 2014-02-19
Last updated: 2019-12-05
Other registries' IDs: eudract:2013-004494-28
Results first posted: 2019-11-20

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death	Up to 4.6 years	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.
Secondary	Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)	Up to 4.6 years	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.
Secondary	Major Adverse Cardiac Event (MACE)	Up to 4.6 years	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.
Secondary	Hospitalized Heart Failure (HHF)	Up to 4.6 years	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.
Secondary	Renal Composite Endpoint	Up to 4.6 years	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.
Secondary	Cardiovascular (CV) Death	Up to 4.6 years	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.
Secondary	All-cause Mortality	Up to 4.6 years	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.
Secondary	CV Composite Endpoint	Up to 4.6 years	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death	Up to 4.6 years	The Intent-to-treat (ITT) population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)	Up to 4.6 years	The ITT population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	Major Adverse Cardiac Event (MACE)	Up to 4.6 years	The ITT population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	Hospitalized Heart Failure (HHF)	Up to 4.6 years	The ITT population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	Renal Composite Endpoint	Up to 4.6 years	The ITT population consisted of all randomized participant.	Event rate per 1000 participant-years	NUMBER
SECONDARY	Cardiovascular (CV) Death	Up to 4.6 years	The ITT population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	All-cause Mortality	Up to 4.6 years	The ITT population consisted of all randomized participants.	Event rate per 1000 participant-years	NUMBER
SECONDARY	CV Composite Endpoint	Up to 4.6 years	The ITT population consisted of all randomized participant.	Event rate per 1000 participant-years	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death	Placebo	61.24	Event rate per 1000 participant-years
Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death	Canagliflozin 100 mg	43.21	Event rate per 1000 participant-years
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)	Placebo	45.44	Event rate per 1000 participant-years
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)	Canagliflozin 100 mg	31.47	Event rate per 1000 participant-years
Major Adverse Cardiac Event (MACE)	Placebo	48.67	Event rate per 1000 participant-years
Major Adverse Cardiac Event (MACE)	Canagliflozin 100 mg	38.71	Event rate per 1000 participant-years
Hospitalized Heart Failure (HHF)	Placebo	25.33	Event rate per 1000 participant-years
Hospitalized Heart Failure (HHF)	Canagliflozin 100 mg	15.65	Event rate per 1000 participant-years
Renal Composite Endpoint	Placebo	40.36	Event rate per 1000 participant-years
Renal Composite Endpoint	Canagliflozin 100 mg	26.99	Event rate per 1000 participant-years

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	2,199
Overall Study	STARTED	Canagliflozin 100 mg	2,202
Overall Study	Treated	Placebo	2,197
Overall Study	Treated	Canagliflozin 100 mg	2,200
Overall Study	COMPLETED	Placebo	2,174
Overall Study	COMPLETED	Canagliflozin 100 mg	2,187
Overall Study	NOT COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Canagliflozin 100 mg	15

Source ClinicalTrials.gov

Adverse events1,504

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Placebo	136	2,197
other	Anaemia	Blood and lymphatic system disorders	Canagliflozin 100 mg	77	2,200
other	Vertigo	Ear and labyrinth disorders	Placebo	50	2,197
other	Vertigo	Ear and labyrinth disorders	Canagliflozin 100 mg	46	2,200
other	Cataract	Eye disorders	Placebo	80	2,197
other	Cataract	Eye disorders	Canagliflozin 100 mg	58	2,200
other	Diabetic Retinopathy	Eye disorders	Placebo	55	2,197
other	Diabetic Retinopathy	Eye disorders	Canagliflozin 100 mg	65	2,200
other	Constipation	Gastrointestinal disorders	Placebo	82	2,197
other	Constipation	Gastrointestinal disorders	Canagliflozin 100 mg	80	2,200

1 to 10 of 1,504Source ClinicalTrials.gov

See all 1,504 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	193	2,197
Total, all-cause mortality	Canagliflozin 100 mg	164	2,200
Total, other adverse events	Placebo	1,447	2,197
Total, other adverse events	Canagliflozin 100 mg	1,320	2,200
Total, serious adverse events	Placebo	806	2,197
Total, serious adverse events	Canagliflozin 100 mg	737	2,200

Source ClinicalTrials.gov

Papers47

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29253846	DERIVED	PubMed
30990260	DERIVED	PubMed
31291786	DERIVED	PubMed
31707795	DERIVED	PubMed
32354987	DERIVED	PubMed
32930969	DERIVED	PubMed
33263893	DERIVED	PubMed
33340064	DERIVED	PubMed
33358942	DERIVED	PubMed
33554616	DERIVED	PubMed

1 to 10 of 47

See all 47 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Canagliflozin 100 mg vs Placebo: deaths from any cause	Trial comparisons
Canagliflozin 100 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02065791

GET https://conductscience.org/api/trials/v1/NCT02065791/events?page=2

API reference For AI assistants