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Phase 3 N=922 Randomized Quadruple-blind Treatment

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

CKD Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01750190 ↗
Enrolled (actual)
922
Serious AEs
48.1%
Results posted
Oct 2021
Primary outcome: Primary: United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy — 9.10; 9.09; 2.00; 0.16 g/dL — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Roxadustat (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Kyntra Bio
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy		 9.10; 9.09; 2.00; 0.16 <0.0001 sig
PRIMARY
Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy		 523; 20 <0.0001 sig
SECONDARY
Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy		 9.09; 9.09; 2.02; 0.20 <0.0001 sig
SECONDARY
Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)		 9.10; 8.99; 2.02; 0.18 <0.0001 sig
SECONDARY
Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy		 467; 56 <0.0001 sig
SECONDARY
Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28		 97.74; 96.39; -18.48; 0.22 <0.0001 sig
SECONDARY
Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)		 -2.89; -3.10 0.6924
SECONDARY
Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment		 34; 47 <0.0001 sig
SECONDARY
Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment		 29; 61; 54; 88 <0.0001 sig
SECONDARY
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28		 41.16; 41.35; 0.33; -0.27; 48.19; 47.62 —
SECONDARY
Number (%) of Participants Who Experienced Exacerbation of Hypertension		 140; 48 —
SECONDARY
Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28		 92.16; 91.53; 0.02; -0.12 —

Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Eligibility Criteria

Inclusion Criteria

  • Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
  • Anemia qualified by measurements of hemoglobin values during screening
  • Additional blood work must be in a safe range for study entry
  • Body weight 45 to 160 kilograms (kg)
  • Willingness to use contraception if of child-bearing potential

Exclusion Criteria

  • Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
  • More than 1 dose of intravenous iron within 12 weeks prior to study participation
  • Blood transfusion within 8 weeks prior to study participation
  • Active infection
  • Chronic liver disease
  • Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
  • Uncontrolled blood pressure within 2 weeks prior to study participation
  • Renal cell carcinoma
  • History of malignancy, including multiple myeloma or other myelodysplastic syndrome
  • Chronic inflammatory disease that could impact red blood cell production
  • Any prior organ transplant or a scheduled organ transplantation
  • Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
  • Gastrointestinal bleeding
  • Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  • Recent use of an investigational drug or treatment, or participation in an investigational study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01750190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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