Supplementary Material for: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics

  • Meg J. Jardine (Creator)
  • Kenneth W. Mahaffey (Creator)
  • Bruce Neal (Creator)
  • Rajiv Agarwal (Creator)
  • George Bakris (Creator)
  • Barry M. Brenner (Creator)
  • Scott Bull (Creator)
  • Christopher P. Cannon (Creator)
  • David M. Charytan (Creator)
  • Dick de Zeeuw (Creator)
  • Robert Edwards (Creator)
  • Tom Greene (Creator)
  • Hiddo Lambers Heerspink (Contributor)
  • Adeera Levin (Creator)
  • Carol Pollock (Creator)
  • David C. Wheeler (Creator)
  • John Xie (Creator)
  • Hong Zhang (Creator)
  • Bernard Zinman (Creator)
  • Mehul Desai (Creator)
  • Vlado Perkovic (Creator)

Dataset

Description

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 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.
Datum van beschikbaarheid13-dec.-2017
UitgeverKarger Publishers

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