Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Phase 4

Completed

• Conditions: Renal Anemia
• Interventions: Drug: Roxadustat

• Registration Number: NCT04454879
• Lead Sponsor: Peking University First Hospital

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 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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study Start: 2020-07-01
• Study First Posted: 2020-07-02
• Primary Completion: 2021-04-03
• Study Completion: 2021-08-03
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lower roxadustat dosage group	Roxadustat	Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.
standard roxadustat dosage group	Roxadustat	Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.

Primary Outcome Measures

Name	Time	Method
The ratio of hemoglobin achieving the target (115g/L)	12 weeks	The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.

Secondary Outcome Measures

Name	Time	Method
The ratio of hemoglobin over-shooting	12 weeks	Hemoglobin higher than 130g/L during the follow-up.
The variation ratio of hemoglobin	12 weeks	The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China