Early for Positive Efficacy Findings
– INVOKANA® has the potential to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with type 2 diabetes
– Worldwide, 160 million patients with type 2 diabetes are at risk for developing chronic kidney disease
– CREDENCE assessed INVOKANA® for renal protection by evaluating the risk reduction of the composite endpoint of time to dialysis or kidney transplantation, doubling of serum creatinine, and renal or cardiovascular death, when used in addition to standard of care
RARITAN, N.J., July 16, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) clinical trial, evaluating the efficacy and safety of INVOKANA® (canagliflozin) versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), is being stopped early based on the achievement of pre-specified efficacy criteria.
The decision is based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis. This recommendation was based on demonstration of efficacy, as the trial had achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care … read more