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Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Renal Anemia Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04454879
Study type Interventional
Source Peking University First Hospital
Contact
Status Completed
Phase Phase 4
Start date July 1, 2020
Completion date August 3, 2021
View Details
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