Canagliflozin Trial for T2D, CKD Halted Due to Positive Results
After conducting an interim analysis the Independent Data Monitoring Committee recommended stopping the trial based on its demonstration of efficacy.
A clinical trial assessing canagliflozin (Invokana; Janssen) as an addition to standard-of-care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has been stopped early after meeting its pre-specified efficacy criteria.
The Phase 3 CREDENCE trial was a double-blind, placebo-controlled study (N=4400) that assessed renal outcomes in patients with T2D and CKD on background therapy including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). The study evaluated whether the addition of canagliflozin reduced the risk of the composite endpoint of time to dialysis or kidney transplantation, doubling of serum creatinine, and renal or cardiovascular death. All patients were required to be on the maximum labeled or tolerated dose of an ACE inhibitor or ARB for more than 4 weeks prior to randomization.
During a planned interim analysis, the Independent Data Monitoring Committee recommended stopping the trial based on its demonstration of efficacy, as pre-specified criteria were met for the primary composite endpoint of end-stage kidney disease. "We look forward to presenting the full data from the CREDENCE trial at an upcoming medical meeting and with health authorities in the near future," said James List, MD, PhD, of Janssen Research and Development.
Invokana is approved an an adjunct to diet and exercise to improve glycemic control in adults with T2D. Currently, it is contraindicated in patients with severe renal impairment (eGFR <30mL/min/1.73m2) and is not recommended for patients when eGFR is persistently <45mL/min/1.73m2.
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