Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Renal Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454879
• Other study ID #: Roxadustat,different dose,
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: August 3, 2021

Study information

• Verified date: November 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 3, 2021
• Est. primary completion date: April 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Renal Anemia

Intervention

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Haidian Hospital, Beijing Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The variation ratio of hemoglobin	The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin	12 weeks
Secondary	The ratio of hemoglobin over-shooting	Hemoglobin higher than 130g/L during the follow-up.	12 weeks