Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

NCT04454879 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Roxadustat，different dose,
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Anemia

Keywords

Roxadustat; renal anemia; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The variation ratio of hemoglobin

  12 weeks

• The ratio of hemoglobin over-shooting

  12 weeks

Study Arms (2)

standard roxadustat dosage group

EXPERIMENTAL

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

Drug: Roxadustat

lower roxadustat dosage group

EXPERIMENTAL

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

Drug: Roxadustat

Interventions

Roxadustat 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; standard roxadustat dosage group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients diagnosed with Chronic kidney disease stage 5
• Maintenance on PD for more than three months.
• Weight between 45Kg and 110Kg
• Renal anemia, and hemoglobin between 90g/L and 120g/L
• 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
• Signed the informed consent.
• Willing to follow the study procedure

You may not qualify if:

• Hematologic malignancy or aplastic anemia.
• Blood loss or hemolysis.
• Taking roxadustat, or Allergy or intolerance to roxadustat
• Severe liver injury or active hepatitis.
• Pregnancy or breastfeeding
• Cancer, receiving radiotherapy and chemotherapy within 6 months.
• Refractory hypertension

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Haidian Hospital: collaborator
• Beijing Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 35257058 DERIVED

MeSH Terms

Interventions

roxadustat

Study Officials

• Jie Dong, MD

  Peking University First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: April 3, 2021
• Study Completion: August 3, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)