NCT04454879

Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients

Detailed description

Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb variation and adverse subsequences. Therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable Hb target at week 12 while lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort. Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	Roxadustat	Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-04-03
• Completion: 2021-08-03
• First posted: 2020-07-02
• Last updated: 2021-11-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study