Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

NCT ID: NCT04454879

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-08-03

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.

Conditions

Renal Anemia

Keywords

Roxadustat; renal anemia; Peritoneal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard roxadustat dosage group

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

Group Type: EXPERIMENTAL

Roxadustat

Intervention Type: DRUG

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.

lower roxadustat dosage group

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

Group Type: EXPERIMENTAL

Roxadustat

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Haidian Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Jie

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Dong, MD

Role: STUDY_DIRECTOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, , China

Countries

China

References

Yang Z, Ma T, Xu X, Fu G, Zhao J, Xu Y, Yang B, Song D, Zhu S, Lv J, Dong J. Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis. Kidney Int Rep. 2021 Dec 27;7(3):455-464. doi: 10.1016/j.ekir.2021.12.025. eCollection 2022 Mar.

Reference Type: DERIVED

PMID: 35257058 (View on PubMed)

Other Identifiers

Roxadustat，different dose,

Identifier Type: -

Identifier Source: org_study_id