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

Kyntra Bio60 enrolled

Overview

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.

Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, respectively, in addition to roxadustat. At the same time, participants on peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD participants, and is an optional, confirmatory/supplemental treatment arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 treatment arms. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight \[40 to 60 kilograms {kg}\], medium weight \[\>60 to 90 kg\], and heavy weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dialysis Anemia

Interventions

RoxadustatDRUG

Tiered, weight-based dosing per schedule specified in the arm.

Oral IronDRUG

Administered per oral dose and schedule specified in the arm.

IV IronDRUG

Administered per IV dose and schedule specified in the arm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (7)

Unnamed facility

Northridge, California, United States

Unnamed facility

Yuba City, California, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Maximum Change From Baseline in Hb During Weeks 3-13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.

Time frame: Baseline, Weeks 3-13

Secondary Outcomes

Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Time frame: Baseline, Weeks 2-5, 6-9, and 10-13

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

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Time frame: Week 3 to 13

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

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Time frame: Week 3 to 13

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

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Time frame: Weeks 5, 9, and 13

Number of Participants Who Achieved Maximum Hb During Weeks 3-13

Time frame: Weeks 3-13

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.