Kidney Week

Abstract: SA-OR078

Renal, Cardiovascular, and Safety Outcomes of Canagliflozin (CANA) According to Baseline Kidney Function: A CREDENCE Secondary Analysis

Session Information

• Moving the Needle for Treatment of Diabetic Kidney Disease
  November 09, 2019 | Location: Ballroom C, Walter E. Washington Convention Center
  Abstract Time: 04:30 PM - 04:42 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Jardine, Meg J., The George Institute for Global Health, UNSW, Newtown, New South Wales, Australia

Meg J. Jardine, MBBS, PhD

• Mahaffey, Kenneth W., Stanford University School of Medicine, Stanford, California, United States

Kenneth W. Mahaffey,

• Agarwal, Rajiv, Indiana University School of Medicine and VA Medical Center, Indianapolis, Indiana, United States

Rajiv Agarwal,

• Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States

George L. Bakris,

• Baldassarre, James S., Janssen Research & Development, LLC, Raritan, New Jersey, United States

James S. Baldassarre,

• Brenner, Barry M., Brigham and Women’s Hospital, Harvard Medical School and Baim Institute for Clinical Research, Boston, Massachusetts, United States

Barry M. Brenner,

• Bull, Scott, Janssen Research & Development, LLC, Raritan, New Jersey, United States

Scott Bull,

• Charytan, David M., NYU School of Medicine and NYU Langone Medical Center, Boston, New York, United States

David M. Charytan,

• Greene, Tom, University of Utah, Salt Lake City, Utah, United States

Tom Greene,

• Levin, Adeera, University of British Columbia, Vancouver, British Columbia, Canada

Adeera Levin,

• Neal, Bruce, The George Institute for Global Health, UNSW, Newtown, New South Wales, Australia

Bruce Neal,

• Rosenthal, Norm, Janssen Research & Development, LLC, Raritan, New Jersey, United States

Norm Rosenthal,

• Sun, Tao, Janssen Research & Development, LLC, Raritan, New Jersey, United States

Tao Sun,

• Qiu, Rose, Janssen Research & Development, LLC, Raritan, New Jersey, United States

Rose Qiu,

• Zhang, Hong, Renal Division of Peking University First Hospital, Beijing, China

Hong Zhang,

• Zhou, Zien, The George Institute for Global Health, UNSW, Newtown, Australia

Zien Zhou,

• Zinman, Bernard, Lunenfeld-Tanenbaum Research Institute, Mt Sinai Hospital, University of Toronto, Toronto, Ontario, Canada

Bernard Zinman,

• Perkovic, Vlado, Concord Repatriation General Hospital, Sydney, New South Wales, Australia

Vlado Perkovic,

Background

CANA is approved in people with type 2 diabetes and eGFR ≥45mL/min/1.73m². We assessed its efficacy and safety according to eGFR strata including the 30-<45mL/min/1.73m² stratum.

Methods

The CREDENCE study enrolled 4401 participants with eGFR 30-<90mL/min/1.73m² and urinary albumin:creatinine ratio >300-5000mg/g, randomizing them within eGFR-based strata to CANA 100mg daily or matching placebo. Primary and prespecified secondary composites and safety outcomes were analyzed using Cox proportional hazards regression within each screening eGFR stratum 30-<45, 45-<60 and 60-<90mL/min/1.73m².

Results

At screening, 1313 (29.8%), 1279 (29.1%), and 1809 (41.1%) participants had an eGFR 30-<45, 45-<60 and 60-<90ml/min/1.73m². Overall, CANA reduced the primary outcome, the renal composite of ESKD, sustained doubling serum creatinine (SCr) or renal death, a range of CV outcomes and serious adverse events with no impact on fractures or amputations. There was no evidence the impact of CANA differed between eGFR subgroups (all P-interaction >0.11, Figure). The benefits of CANA were individually significant in people with a screening eGFR 30-<45ml/min/1.73m² for the primary composite, renal composite and composite of CV death or hospitalization for heart failure (95%CI upper limit <1.00).

Conclusion

CANA safely reduces the risk of renal and CV events in people with type 2 diabetes and substantial albuminuria, and these benefits are preserved across a spectrum of eGFR 30-<90ml/min/1.73m², including eGFR 30-<45/min/1.73m².

Funding

• Commercial Support –