Janssen ends CREDENCE trial early after meeting efficacy goals

18th July 2018 (Last Updated July 18th, 2018 00:00)

Janssen Pharmaceutical Companies of Johnson & Johnson has stopped the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) clinical trial ahead of schedule after meeting the efficacy endpoints of the trial.

Janssen Pharmaceutical Companies of Johnson & Johnson has stopped the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) clinical trial ahead of schedule after meeting the efficacy endpoints of the trial.

The decision follows a recommendation given by the trial’s Independent Data Monitoring Committee (IDMC) after completing a planned interim analysis of the study data.

CREDENCE is a Phase lll study evaluating the efficacy and safety of Invokana (canagliflozin) versus placebo when used along with standard of care for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

The randomised, double-blind, placebo-controlled, parallel-group, multicentre trial enrolled around 4,400 patients with T2D.

All the patients were on the maximum labelled or tolerated dose of an ngiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for more than four weeks before randomisation.

"This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago."

The primary composite endpoint of the trial included end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used along with standard of care.

CREDENCE Steering Committee co-chair Vlado Perkovic said: “Nearly half of all people with type 2 diabetes will develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease, and impacting their quality and length of life, even with the current best available care.

“This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago.”

Invokana is currently suggested for lower blood sugar in adults with type 2 diabetes, but has not been prescribed for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine).