Clinical trial NCT01414075
Conditions: Dialysis Anemia
Keywords: Kidney ESRD Renal End-Stage Renal Disease Anemia Oral anemia treatment Hemoglobin levels Hemodialysis Peritoneal HD PD Hb Erythropoietin Blood count
Sponsor: FibroGen
Start date: 2011-07-21; Completion date: 2013-01-10
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally 3 times weekly (TIW) for 12 weeks. arm 2: Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. arm 3: Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks. arm 4: Participants on PD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Interventions: intervention 1: Roxadustat intervention 2: Oral Iron intervention 3: IV Iron
Intervention descriptions: intervention 1: Tiered, weight-based dosing per schedule specified in the arm. intervention 2: Administered per oral dose and schedule specified in the arm. intervention 3: Administered per IV dose and schedule specified in the arm.

Protocol documents: