Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Peking University

Status and phase: Completed; Phase 4

Conditions: Renal Anemia

Treatments: Drug: Roxadustat

Study type: Interventional

Funder types: Other

Identifiers

NCT04454879

Roxadustat，different dose,

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

standard roxadustat dosage group

Experimental group

Description:

Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.

Treatment:

Drug: Roxadustat

lower roxadustat dosage group

Experimental group

Description:

Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.

Treatment:

Drug: Roxadustat