Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04454879

Collaborator

Beijing Haidian Hospital (Other), Beijing Hospital of Traditional Chinese Medicine (Other)

100

Enrollment

Location

Arms

13.1

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Renal Anemia	Drug: Roxadustat	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Apr 3, 2021

Actual Study Completion Date :

Aug 3, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing		China

Sponsors and Collaborators

Peking University First Hospital
Beijing Haidian Hospital
Beijing Hospital of Traditional Chinese Medicine

Investigators

Study Director: Jie Dong, MD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong Jie, Clinical Professor, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT04454879

Other Study ID Numbers:

Roxadustat，different dose,

First Posted:

Jul 2, 2020

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Dong Jie, Clinical Professor, Peking University First Hospital

Roxadustat

renal anemia

Peritoneal Dialysis

Additional relevant MeSH terms:

Anemia

Study Results

No Results Posted as of Nov 26, 2021