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

May 3, 2022 updated by: FibroGen

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

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)

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100044
        • Investigational Site
      • Beijing, China, 100191
        • Investigational Site
      • Beijing, China, 100730
        • Investigational Site
      • Shanghai, China, 200025
        • Investigational Site
      • Tianjin, China, 300052
        • Investigational Site
    • Anhui
      • Hefei, Anhui, China, 230601
        • Investigational Site
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Investigational Site
      • Shenzhen, Guangdong, China, 518020
        • Investigational Site
    • Guangxi Province
      • Nanning, Guangxi Province, China, 530021
        • Investigational Site
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Investigational Site
    • Inner Mongolia Autonomous Region
      • Baotou, Inner Mongolia Autonomous Region, China, 014010
        • Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Investigational Site
    • Jilin
      • Chang chun, Jilin, China, 130021
        • Investigational Site
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Investigational Site
      • Shenyang, Liaoning, China, 110122
        • Investigational Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Investigational Site
      • Xi'an, Shanxi, China, 710004
        • Investigational Site
      • Xi'an, Shanxi, China, 710061
        • Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Investigational Site
      • Chengdu, Sichuan, China, 610072
        • Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
  2. 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.
  3. History of malignancy, myelodysplastic syndrome, and multiple myeloma.
  4. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
  5. Clinically significant gastrointestinal bleeding.
  6. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: ESA-Naïve Participants - Low Weight Based Dosing
ESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 1: ESA-Naïve Participants - Standard Weight Based Dosing
ESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 1: ESA-Treated Participants - Low Weight Based Dosing
ESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to <60 kg or 100 mg TIW for body weight ≥60 kg.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 1: ESA-Treated Participants - Standard Weight Based Dosing
ESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to <60 kg or 120 mg TIW for body weight ≥60 kg.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 2: Roxadustat QW
Participants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 2: Roxadustat BIW
Participants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592
Experimental: Part 2: Roxadustat TIW
Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline.
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other Names:
  • FG-4592

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Time Frame: Weeks 1 to 20
Weeks 1 to 20
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
Weeks 17 to 21
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Time Frame: Weeks 33 to 37
Weeks 33 to 37

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Time Frame: Baseline, Weeks 17 to 21
Baseline, Weeks 17 to 21
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
Weeks 17 to 21
Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Time Frame: Weeks 33 to 37
Weeks 33 to 37

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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