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Vlado Perkovic, PhD Janssen Pharmaceutical Johnson & Johnson companies announced the early end of a phase 3 of canagliflozin (Invokana) for the treatment of patients with chronic renal failure and type 2 diabetes, due to the Pre-established efficacy endpoints The study of Canagliflozin and renal events in diabetes with clinical evaluation of established neuropathy (CREDENCE), a comparative study of the efficacy and the efficacy of safety of canagliflozin compared to placebo, was concluded on the basis of an interim data badysis.
Based on a recommendation from an independent Data Monitoring Committee (IDMC), Janssen decided to terminate the trial when it was established that he had already met predefined criteria for his primary composite end stage renal disease parameter. kidney dialysis or transplantation – the doubling of serum creatinine and renal or cardiovascular death.
Canagliflozin was administered to patients
CREDENCE – the first trial devoted to a standard of care treatment setting measuring renal outcomes in patients with CTD and T2D – was a randomized study , double-blind, placebo-controlled centers. It included approximately 4400 patients with T2D, with an estimated glomerular filtration rate (eFGR) ≥ 30 at <90 mL / min / 1.73 m 2 and albuminuria.
All participating patients were labeled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor antagonists (ARBs). for more than 4 weeks before randomization.
The patient population emphasizes the importance of preventive treatments in T2D patients at risk for CKD. Cut. Vlado Perkovic, Ph.D., co-chair of the CREDENCE Steering Committee and Professor of Medicine at the University of New South Wales in Sydney, said nearly half of people with T2DM would develop chronic kidney disease .
"This unmet need is the reason why it was so important for us to initiate the major test on CREDENCE's kidney outcomes over four years ago," Perkovic said. . "We have accepted the opinion of the Independent Data Monitoring Committee to stop the CREDENCE trial because of the demonstration of efficiency, and we look forward to sharing the results as soon as possible."
The month before the sudden end of CREDENCE was a notable moment for canagliflozin. New data from the CANVAS and CANVAS-R trials, presented at the 78th Annual Scientific Sessions of the 2018 American Diabetes Association in Orlando, Florida, reported that treatment was badociated with decreased risk of renal loss eFGR, and reduction of albuminuria compared with placebo.
Canagliflozin also did not increase the risk of amputation below the knee in patients with T2D compared to other anti-hyperglycemic therapies. indicates a risk of amputation of the legs and feet.
James List, MD, Ph.D., responsible for the cardiovascular and metabolic area, Janssen Research & Development, said that complete data from the CREDENCE trial will be presented at an upcoming medical meeting . and with the health authorities in the near future. "
" We are excited about the opportunity to make Invokana the first treatment for treating patients with chronic kidney failure. and type 2 diabetes in over 15 years, "said List.
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