– 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[i]
– 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, NJ, USA I July 16, 2018 I 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.
“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. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” said Vlado Perkovic, M.B.B.S, Ph.D., F.A.S.N., F.R.A.C.P., CREDENCE Steering Committee co-chair, Professor of Medicine, University of New South Wales Sydney, and Executive Director, The George Institute for Global Health Australia. “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.”
“Chronic kidney disease is a progressive condition that impacts a person’s overall health and well-being, and with millions of people worldwide suffering from the disease, we know that there is a clear need for new treatment options,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We are excited about the possibility of bringing forth INVOKANA® (canagliflozin) as the first therapy to treat patients with chronic kidney disease and type 2 diabetes in more than 15 years. We look forward to presenting the full data from the CREDENCE trial at an upcoming medical meeting and with health authorities in the near future.”
CREDENCE is the first dedicated renal outcomes trial in patients with CKD and T2D on the background of standard of care, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). This randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial evaluates the efficacy and safety of canagliflozin versus placebo in preventing clinically important renal and CV outcomes in patients with T2D and established kidney disease. The trial enrolled approximately 4,400 patients with T2D, estimated glomerular filtration rate ≥30 to <90 mL/min/1.73 m2, and albuminuria (urinary albumin: creatinine ratio >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.
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 (ESRD), or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. Please see the Important Safety Information below and the full Prescribing Information for additional details.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
SOURCE: Janssen
Post Views: 30
– 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[i]
– 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, NJ, USA I July 16, 2018 I 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.
“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. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” said Vlado Perkovic, M.B.B.S, Ph.D., F.A.S.N., F.R.A.C.P., CREDENCE Steering Committee co-chair, Professor of Medicine, University of New South Wales Sydney, and Executive Director, The George Institute for Global Health Australia. “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.”
“Chronic kidney disease is a progressive condition that impacts a person’s overall health and well-being, and with millions of people worldwide suffering from the disease, we know that there is a clear need for new treatment options,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We are excited about the possibility of bringing forth INVOKANA® (canagliflozin) as the first therapy to treat patients with chronic kidney disease and type 2 diabetes in more than 15 years. We look forward to presenting the full data from the CREDENCE trial at an upcoming medical meeting and with health authorities in the near future.”
CREDENCE is the first dedicated renal outcomes trial in patients with CKD and T2D on the background of standard of care, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). This randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial evaluates the efficacy and safety of canagliflozin versus placebo in preventing clinically important renal and CV outcomes in patients with T2D and established kidney disease. The trial enrolled approximately 4,400 patients with T2D, estimated glomerular filtration rate ≥30 to <90 mL/min/1.73 m2, and albuminuria (urinary albumin: creatinine ratio >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.
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 (ESRD), or patients on dialysis. In addition, INVOKANA® is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2. Please see the Important Safety Information below and the full Prescribing Information for additional details.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
SOURCE: Janssen
Post Views: 30
