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Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

NCT04454879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-26

No results posted yet for this study

Summary

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

Conditions

  • Renal Anemia

Interventions

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.

Sponsors & Collaborators

  • Beijing Haidian Hospital

    collaborator OTHER

  • Beijing Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Jie Dong, MD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-04-03
Completion
2021-08-03
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454879 on ClinicalTrials.gov