Clinical trial NCT04454879: Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
Official title: Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Anemia
Keywords: Roxadustat
renal anemia
Peritoneal Dialysis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Haidian Hospital
name: Beijing Hospital of Traditional Chinese Medicine
First posted: 2020-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The ratio of hemoglobin achieving the target (115g/L)
timeFrame: 12 weeks
Secondary outcomes:
measure: The variation ratio of hemoglobin
timeFrame: 12 weeks
measure: The ratio of hemoglobin over-shooting
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Jie Dong, MD
role: STUDY_DIRECTOR
References:
citation: 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.