Status:
COMPLETED
Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Beijing Haidian Hospital
Beijing Hospital of Traditional Chinese Medicine
Conditions:
Renal Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Adult patients diagnosed with Chronic kidney disease stage 5
- Maintenance on PD for more than three months.
- Weight between 45Kg and 110Kg
- Renal anemia, and hemoglobin between 90g/L and 120g/L
- Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using erythropoietin of 10000U single strength） or free of erythropoietin use
- Signed the informed consent.
- Willing to follow the study procedure
Exclusion
- Hematologic malignancy or aplastic anemia.
- Blood loss or hemolysis.
- Taking roxadustat, or Allergy or intolerance to roxadustat
- Severe liver injury or active hepatitis.
- Pregnancy or breastfeeding
- Cancer, receiving radiotherapy and chemotherapy within 6 months.
- Refractory hypertension
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04454879
Start Date
July 1 2020
End Date
August 3 2021
Last Update
November 26 2021
Active Locations (1)
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1
Peking University First Hospital
Beijing, China