16 April 2019 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business has received new results from the Phase 3 CREDENCE study, showing that Invokana (canagliflozin) demonstrated a 30% reduction in the risk of the primary composite endpoint, comprised of progression to end-stage kidney disease, defined as the need for renal replacement therapy such as chronic dialysis or renal transplant; doubling of serum creatinine, a key predictor of ESKD; and renal or cardiovascular death, the company said.

The landmark study evaluated the efficacy and safety of Invokana versus placebo in patients with chronic kidney disease and type 2 diabetes when used in addition to standard of care.

Study results also showed Invokana reduced the risk of the secondary CV endpoints, including the risk of CV death and hospitalization for heart failure by 31%, major adverse CV events (MACE; composite of nonfatal myocardial infarction [MI], nonfatal stroke and CV death) by 20%, and the risk of hospitalisation for heart failure alone by 39%.

Importantly, the study showed no imbalance in amputation or bone fracture. Additionally, no new safety concerns were identified in this study of high-risk patients.

The data were presented TODAY during a late-breaking clinical trials session at the International Society of Nephrology 2019 World Congress of Nephrology in Melbourne, Australia, and simultaneously published in The New England Journal of Medicine.

The Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, NCT02065791) clinical trial was a randomized, double-blind, event-driven, placebo-controlled, parallel-group, 2-arm, multicenter study.

It evaluated 4,401 patients with T2D, Stage 2 or 3 CKD (defined as an estimated glomerular filtration rate of ≥30 to 300 to ≤5,000 mg/g), who were receiving standard of care including a maximum tolerated labeled daily dose of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.

In March 2019, Janssen included the CREDENCE data in the submission of a supplemental New Drug Application to the US FDA for Invokana to reduce the risk of ESKD, the doubling of serum creatinine, and renal or CV death for adults with CKD and T2D.

This followed an Independent Data Monitoring Committee meeting in July 2018, where the committee recommended that the CREDENCE trial stop early because it met the prespecified criteria for efficacy.

If this new indication is approved, Invokana would be the first diabetes medication to treat both T2D and CKD, and could be an important new treatment option for the ms of patients around the world who live with these illnesses.

In the CREDENCE study, Invokana showed a 30% reduction in the risk of the primary composite endpoint comprised of progression to doubling of serum creatinine, ESKD, and renal or CV death (HR: 0.70; 95% CI: 0.59 to 0.82; p