Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

• Status: Recruiting
• Trial end date: 2021-08-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Beijing Haidian Hospital; Beijing Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

1. Adult patients diagnosed with Chronic kidney disease stage 5

2. Maintenance on PD for more than three months.

3. Weight between 45Kg and 110Kg

4. Renal anemia, and hemoglobin between 90g/L and 120g/L

5. 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

6. Signed the informed consent.

7. Willing to follow the study procedure

Exclusion Criteria:

1. Hematologic malignancy or aplastic anemia.

2. Blood loss or hemolysis.

3. Taking roxadustat, or Allergy or intolerance to roxadustat

4. Severe liver injury or active hepatitis.

5. Pregnancy or breastfeeding

6. Cancer, receiving radiotherapy and chemotherapy within 6 months.

7. Refractory hypertension