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NCT Number: NCT04454879

Different Doses of Roxadustat Treatment for Anemia 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

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Key information

Conditions

Renal Anemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The ratio of hemoglobin achieving the target (115g/L)

    Time frame: 12 weeks

    The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.

Secondary outcomes

  1. The variation ratio of hemoglobin

    Time frame: 12 weeks

    The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin

  2. The ratio of hemoglobin over-shooting

    Time frame: 12 weeks

    Hemoglobin higher than 130g/L during the follow-up.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Haidian Hospital
  • Beijing Hospital of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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