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

By December 10, 2017September 24th, 2020No Comments

LINK TO RESEARCH
https://pubmed.ncbi.nlm.nih.gov/29253846/

PUBLICATION
American Journal of Nephrology

AUTHORS
Meg J Jardine 1 2 ,
Kenneth W Mahaffey 3 ,
Bruce Neal 1 4 5 6 ,
Rajiv Agarwal 7 ,
George L Bakris 8 ,
Barry M Brenner 9 ,
Scott Bull 10 ,
Christopher P Cannon 11 ,
David M Charytan 12 ,
Dick de Zeeuw 13 ,
Robert Edwards 10 ,
Tom Greene 14 ,
Hiddo J L Heerspink 13 ,
Adeera Levin 15 ,
Carol Pollock 16 ,
David C Wheeler 17 ,
John Xie 10 ,
Hong Zhang 18 ,
Bernard Zinman 19 ,
Mehul Desai 10 ,
Vlado Perkovic 1 ,
CREDENCE study investigators

ABSTRACT
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.

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