Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients

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

Study Overview

• Status: Completed
• Conditions: Renal Anemia
• Intervention / Treatment: Drug: Roxadustat

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University first hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard roxadustat dosage group; Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.	Drug: 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.
Experimental: lower roxadustat dosage group; Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of hemoglobin achieving the target (115g/L)	The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Beijing Haidian Hospital; Beijing Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Jie Dong, MD, Peking University first hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): April 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; Roxadustat; renal anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: Roxadustat，different dose,

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes