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Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients
A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Peking University First Hospital
Beijing, China
Start Date
July 1, 2020
Primary Completion Date
April 3, 2021
Completion Date
August 3, 2021
Last Updated
November 26, 2021
100
ACTUAL participants
Roxadustat
DRUG
Lead Sponsor
Peking University First Hospital
Collaborators
NCT05085275
NCT04408820
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT01888445