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NCT02065791 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,401
- Enrollment target
NCT02065791: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02065791 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 4,401 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (470% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065791, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,401 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Canagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,401 participants |
| Start Date | 2014-02-17 |
| Est. Completion | 2018-10-30 |
| Phase | Phase 3 |
What the finished NCT02065791 record still lists
NCT02065791 is an interventional study that assigns participants to a tested intervention. Its 4,401 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (470% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02065791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02065791 about?
NCT02065791 is a clinical study titled "Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy". 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 recei...
What is the current status of trial NCT02065791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,401 participants. The study started on 2014-02-17. Estimated completion is 2018-10-30.
What interventions are being tested in trial NCT02065791?
The interventions under investigation include: Placebo (DRUG), Canagliflozin (DRUG).
Who is sponsoring clinical trial NCT02065791?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02065791's enrollment target sits among peer trials
4,401 56th of 2000 higher than 1,945 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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