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The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study
Meg J Jardine1,2, Kenneth W Mahaffey3, Bruce Neal1,4,5,6
1The George Institute for Global Health, UNSW Sydney, Sydney, New South Wales, Australia.
Background:
People with diabetes and kidney disease have a high risk of cardiovascular events and progression of kidney disease. Sodium glucose co-transporter 2 inhibitors lower plasma glucose by reducing the uptake of filtered glucose in the kidney tubule, leading to increased urinary glucose excretion. They have been repeatedly shown to induce modest natriuresis and reduce HbA1c, blood pressure, weight, and albuminuria in patients with type 2 diabetes. However, the effects of these agents on kidney and cardiovascular events have not been extensively studied in patients with type 2 diabetes and established kidney disease.
Methods:
The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial aims to compare the efficacy and safety of canagliflozin -versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with diabetes and established kidney disease. CREDENCE is a randomized, double-blind, event-driven, placebo-controlled trial set in in 34 countries with a projected duration of ∼5.5 years and enrolling 4,401 adults with type 2 diabetes, estimated glomerular filtration rate ≥30 to <90 mL/min/1.73 m2, and albuminuria (urinary albumin:creatinine ratio >300 to ≤5,000 mg/g). The study has 90% power to detect a 20% reduction in the risk of the primary outcome (α = 0.05), the composite of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death.
Conclusion:
CREDENCE will provide definitive evidence about the effects of canagliflozin on renal (and cardiovascular) outcomes in patients with type 2 diabetes and established kidney disease.
Trial Registration:
EudraCT number: 2013-004494-28; ClinicalTrials.gov identifier: NCT02065791.
Insights
Sodium glucose co-transporter 2 inhibitors like canagliflozin show promise for patients with type 2 diabetes and kidney disease. The CREDENCE trial investigates their effects on major kidney and cardiovascular events.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- Patients with diabetes and kidney disease face high risks of cardiovascular events and kidney disease progression.
- Sodium glucose co-transporter 2 inhibitors (SGLT2i) reduce glucose by increasing urinary glucose excretion, leading to benefits like reduced HbA1c, blood pressure, and albuminuria in type 2 diabetes.
- However, their impact on kidney and cardiovascular outcomes in patients with established kidney disease is not well-studied.
Purpose of the Study:
- To compare the efficacy and safety of canagliflozin versus placebo in preventing kidney and cardiovascular outcomes.
- To provide definitive evidence on canagliflozin's effects in patients with type 2 diabetes and established kidney disease.
Main Methods:
- The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial is a randomized, double-blind, placebo-controlled study.
- It enrolled 4,401 adults with type 2 diabetes, estimated glomerular filtration rate ≥30 to <90 mL/min/1.73 m2, and albuminuria.
- The primary outcome is a composite of end-stage kidney disease, doubling of serum creatinine, or renal or cardiovascular death.
Main Results:
- The CREDENCE trial is designed to detect a 20% reduction in the primary composite outcome with 90% power.
- Results will elucidate the role of canagliflozin in managing high-risk patients.
Conclusions:
- The CREDENCE trial will offer crucial insights into canagliflozin's renal and cardiovascular benefits.
- This study aims to establish canagliflozin as a therapeutic option for patients with type 2 diabetes and kidney disease.
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