NCT01414075

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

A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Dialysis
• Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Tiered, weight-based dosing per schedule specified in the arm.
DRUG	Oral Iron	Administered per oral dose and schedule specified in the arm.
DRUG	IV Iron	Administered per IV dose and schedule specified in the arm.

Timeline

• Start date: 2011-07-21
• Primary completion: 2013-01-10
• Completion: 2013-01-10
• First posted: 2011-08-11
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

7 sites across 4 countries: United States, Hong Kong, Russia, Singapore