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Abstract: FR-OR131

Pooled Efficacy and Cardiovascular (CV) Analyses of Roxadustat in the Treatment of Anemia in CKD Patients on and Not on Dialysis

Session Information

  • High-Impact Clinical Trials
    November 08, 2019 | Location: Ballroom C, Walter E. Washington Convention Center
    Abstract Time: 02:00 PM - 02:15 PM

Category: Anemia and Iron Metabolism


  • Provenzano, Robert, Wayne State, Detroit, Michigan, United States
  • Fishbane, Steven, Northwell Health, Commack, New York, United States
  • Wei, Lee-Jen, Harvard University, Boston, Massachusetts, United States
  • Szczech, Lynda, FibroGen, Inc., San Francisco, California, United States
  • Leong, Robert, FibroGen, Inc., San Francisco, California, United States
  • Saikali, Khalil Georges, FibroGen, Inc., San Francisco, California, United States
  • Zhong, Ming, FibroGen, Inc., San Francisco, California, United States
  • Lee, Tyson T., FibroGen, Inc., San Francisco, California, United States
  • Houser, Mark T., AstraZeneca, Mölndal, Sweden
  • Frison, Lars, AstraZeneca, Mölndal, Sweden
  • Houghton, John, AstraZeneca, Mölndal, Sweden
  • Neff, Thomas B., FibroGen, Inc., San Francisco, California, United States
  • Yu, Kin-Hung Peony, FibroGen, Inc., San Francisco, California, United States

Group or Team Name

  • Dr. Provenzano and Dr. Fishbane contributed equally.

Roxadustat is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that regulates erythropoiesis & iron metabolism. Integrated Phase 3 analyses examine efficacy & safety of roxadustat in CKD patients (pts).


Phase 3 studies comparing roxadustat to placebo (pbo), in pts with Stage 3-5 non-dialysis-dependent CKD (NDD) & epoetin alfa in dialysis-dependent (DD) patients were pooled. Death, MI, & stroke (MACE), & heart failure or unstable angina requiring hospitalization (MACE+) were adjudicated. Efficacy analyses assessed Hb & rescue therapy (transfusion, IV iron & ESA). CV endpoints included MACE & MACE+.


In NDD, 4270 pts were randomized (2386 roxadustat;1884 pbo). The primary endpoint (mean Hb CFB; Wks 28-52) was +1.85(.94)g/dL in the roxadustat group v. +.13(±1.01)g/dL in pbo (p<.0001) with lower risk of rescue therapy HR(95% CI)=.19 (.16,.23;81% reduction,p<.0001) in roxadustat. Using ITT long-term follow-up, the HR for time to MACE was 1.08(95%CI .94,1.24) for roxadustat vs. pbo, & 1.04(95% CI .91,1.18) for MACE+. In the subgroup with eGFR>10 (n=3431), MACE HR(95% CI)=.99(.84,1.16) & MACE+ HR=.98 (.85,1.14), for roxadustat v. pbo.

In DD, 3917 patients were randomized (1960 roxadustat;1957 epoetin alfa). The primary endpoint (mean Hb CFB Wk 28-52) was 1.21 in roxadustat v. .95 g/dL in EPO (difference .26 g/dL;95%CI .20,.33) in pooled analysis; roxadustat was noninferior & superior to EPO (p<.0001). The roxadustat group received fewer transfusions, 9.5 v.12.8%; HR(95%CI) =.82(.679,.997). Comparing roxadustat with EPO, HR for MACE = .95 (95% CI .81,1.12) & for MACE+ HR=.84 (.73,.97;p=.02) in DD pts. Of 1526 incident pts (dialysis <4 months), HRs for MACE & MACE+ =.70 (95% CI .51,.97)(p=.03) & .66 (95%CI .50,.89)(p=.005).


These integrated Phase 3 analyses provide evidence for roxadustat superiority in anemia correction with transfusion reduction & acceptable CV safety profile.


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