Penn's Renal-Electrolyte and Hypertension Division

View the chronic kidney disease dialysis currently available at Penn Medicine.

Roxadustat: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis

  • Name of PI and Coordinator:
    • Yonghong Huan, MD
    • Debbie Grier, BSN, RN, MBA, CCRP
    • Carla Rivera, CRC
  • Contact:
  • Type of Study:
    Interventional, phase 3
  • Purpose of Study/Patient Population:
    Anemia and CKD. "Oral EPO". Roxadustat is a potent and reversible active hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that transiently induces hypoxia- inducible factor (HIF) stabilization and leads to a functional HIF transcriptional response that mimics the erythropoietic response associated with exposure of humans to intermittent hypoxia.
  • Inclusion:
    Age ≥18 years, stage 3, 4 or 5 CKD not receiving dialysis, Mean Hgb must be <10.0 g/dL, Ferritin ≥50ng/mL, TSAT ≥15 %
  • Exclusion:
    Any erythropoietin analogue treatment within 6 weeks of randomization, New York Heart Association Class III or IV congestive heart failure at enrollment, liver disease, hereditary hematological disorders, BP>160/95.
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