Phase 2 N=60 Randomized Treatment

Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Dialysis · Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01414075 ↗

Enrolled (actual)

Serious AEs

11.7%

Results posted

Oct 2021

Primary outcome: Primary: Maximum Change From Baseline in Hb During Weeks 3-13 — 8.1; 8.5; 8.4; 8.7 grams/deciliter (g/dL) — p=0.0757

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Roxadustat (Drug); Oral Iron (Drug); IV Iron (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kyntra Bio
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Change From Baseline in Hb During Weeks 3-13	8.1; 8.5; 8.4; 8.7; 2.8; 3.5	0.0757
SECONDARY Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13	8.1; 8.5; 8.4; 8.7; 1.1; 1.1	—
SECONDARY Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL	10; 8; 8; 9	—
SECONDARY Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL	17; 10; 8; 10	—
SECONDARY Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13	21; 9; 7; 7; 22; 10	—
SECONDARY Number of Participants Who Achieved Maximum Hb During Weeks 3-13	6; 1; 2; 0; 7; 3	—
SECONDARY Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13	1; 1; 0; 0; 22; 11	—
SECONDARY Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)	4.0; 4.0; 4.0; 4.0	—
SECONDARY Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)	4.2; 4.2; 4.5; 4.3	—
SECONDARY Number of Participants Requiring Dose Increase at Weeks 5 and 9	2; 3; 2; 4; 8; 5	—
SECONDARY Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis	3; 5; 3; 5; 1; 0	—
SECONDARY Change From Baseline in Ferritin at Week 13	156.4; 162.5; 182.0; 137.4; -119.7; -51.1	—
SECONDARY Change From Baseline in Transferrin Saturation (TSAT) at Week 13	18.8; 19.0; 18.1; 19.3; -7.4; 2.6	—
SECONDARY Change From Baseline in Reticulocyte Hemoglobin Content at Week 13	31.0; 31.6; 31.5; 30.4; -2.2; -1.9	—
SECONDARY Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13	6; 5; 4; 5; 5; 2	—
SECONDARY Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL	5; 2; 5; 7	—
SECONDARY Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL	15; 7; 7; 9	—
SECONDARY Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13	0; 0; 0; 0; 0; 1	—
SECONDARY Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13	10; 4; 2; 3; 8; 3	—
SECONDARY Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)	0; 0; 1; 0; 1; 0	—
SECONDARY Number of Participants Requiring Therapeutic Phlebotomy	0; 1; 0; 0	—
SECONDARY Number of Participants Withdrawn From the Study Due to Inadequate Efficacy	0; 0; 0; 0	—
SECONDARY Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13	38.8; 40.7; 41.2; 40.8; 4.8; 1.6	—
SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13	123.5; 118.9; 128.8; 122.8; 8.2; 4.0	—
SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Tests	1; 0; 0; 0; 2; 1	—
SECONDARY Number of Participants With TEAEs	16; 6; 3; 5	—

Summary

The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.

Eligibility Criteria

Inclusion Criteria

Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
Body weight 40 to 140 kilograms (kg)

Exclusion Criteria

Previously received erythropoiesis-stimulating agents
Received IV iron within 4 weeks of randomization
Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
Clinically significant infection
New York Heart Association Class III or IV congestive heart failure
History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
History of other blood disorders
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism
History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
History of allergy or sensitivity to oral or IV iron therapy
Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization
Pregnant or breast-feeding females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01414075). 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.