23 July 2018 - - Janssen Pharmaceutical Companies, a segment of US-based global healthcare company Johnson and Johnson (NYSE: JNJ), has stopped the Phase 3 CREDENCE clinical trial early based on the achievement of pre-specified efficacy criteria, the company said.
The 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), 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 death, when used in addition to standard of care.
CREDENCE, the first dedicated renal outcomes trial in patients with CKD and T2D on the background of standard of care, including angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, enrolled approximately 4,400 patients with T2D, estimated glomerular filtration rate ≥30 to 300 to ≤5,000 mg/g).
All patients were required to be on the maximum labeled or tolerated dose of an ACE inhibitor or ARB for more than four weeks prior to randomization.
Invokana is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
At this time, Invokana is contraindicated for patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.
In addition, Invokana is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2.
The Janssen Pharmaceutical Companies of Johnson and Johnson work to find new and better ways to prevent, intercept, treat, and cure disease. The pharmaceutical segment offers various products in the areas of immunology, infectious diseases and vaccines, neuroscience, oncology, and cardiovascular and metabolic diseases.