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Trial for diabetes drug stopped early after positive results in reducing CKD risk
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The Janssen Pharmaceutical Companies of Johnson & Johnson has ended the phase 3 Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, also known as CREDENCE, based on the achievement of pre-specified efficacy criteria, the company reported.
The goal of the study is to assess whether Invokana (canagliflozin, Janssen Pharmaceuticals Inc.) has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in patients with type 2 diabetes mellitus, stage 2 or 3 CKD and macroalbuminuria.
“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,” Vlado Perkovic, MBBS, PhD, FACN, FRACP, CREDENCE steering committee co-chair, professor of medicine at the University of New South Wales Sydney and executive director of The George Institute for Global Health Australia, said in a company press release. “We have accepted the advice of the independent data monitoring committee to stop the CREDENCE trial early due to demonstration of efficacy and look forward to sharing the findings as soon as possible.”
The trial enrolled approximately 4,400 patients with type 2 diabetes mellitus and an eGFR of at least 30 mL/min/1.73 m2 to less than 90 mL/min/1.73 m2, and albuminuria (urinary albumin: creatinine ratio >300 mg/g to 5,000 mg/g), Janssen said. All patients were required to be on the maximum labeled or tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin 2 receptor blocker for more than 4 weeks prior to randomization.
Currently, Invokana is contraindicated for patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), ESRD or patients on dialysis. In addition, Invokana is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2.
The duration of the study is estimated to be about 5 to 5.5 years.
References:
https://clinicaltrials.gov/ct2/show/study/NCT02065791