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Completed

NCT Number: NCT04059913

Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease

This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.

There are 3 study periods:

* Screening Period (up to 4 weeks) * Treatment Period (36 weeks)

Part 1: Correction/Conversion Period (Weeks 1-20)

Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)

* Follow-up Period (4 weeks)

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Key information

Conditions

CKD Anemia in Dialysis Participants Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site, Hefei, Anhui, China

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About this study

Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:

  • Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight <60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg
  • Standard weight-based dosing: 100 mg TIW for body weight <60 kg or 120 mg TIW for body weight ≥60 kg

After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.

At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)

Exclusion criteria

  • Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
  • Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
  • History of malignancy, myelodysplastic syndrome, and multiple myeloma.
  • Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
  • Clinically significant gastrointestinal bleeding.
  • Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.

Treatment and study plan

Roxadustat

Drug

Roxadustat will be dosed orally per dose and schedule specified in the arm description.

Other names: FG-4592

Primary outcomes

  1. Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks

    Time frame: Weeks 1 to 20

  2. Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits

    Time frame: Weeks 17 to 21

  3. Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits

    Time frame: Weeks 33 to 37

Secondary outcomes

  1. Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits

    Time frame: Baseline, Weeks 17 to 21

  2. Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L

    Time frame: Weeks 17 to 21

  3. Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L

    Time frame: Weeks 33 to 37

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Registry information

Official study title

A Prospective, Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2019
Registry last updated
May 6, 2022

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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