Back to resultsEvaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
Primary Purpose
CKD Anemia in Dialysis Participants
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Roxadustat
Sponsored by
About this trial
This is an interventional treatment trial for CKD Anemia in Dialysis Participants focused on measuring Anemia, Chronic Kidney Disease Dialysis, hemoglobin, End stage renal disease
Eligibility Criteria
Inclusion Criteria:
1. 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.
Sites / Locations
- Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1: ESA-Naïve Participants - Low Weight Based Dosing
Part 1: ESA-Naïve Participants - Standard Weight Based Dosing
Part 1: ESA-Treated Participants - Low Weight Based Dosing
Part 1: ESA-Treated Participants - Standard Weight Based Dosing
Part 2: Roxadustat QW
Part 2: Roxadustat BIW
Part 2: Roxadustat TIW
Arm Description
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.
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.
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.
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.
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.
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.
Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline.
Outcomes
Primary Outcome Measures
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Secondary Outcome Measures
Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L
Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04059913
Brief Title
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD Anemia in Dialysis Participants
Keywords
Anemia, Chronic Kidney Disease Dialysis, hemoglobin, End stage renal disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: ESA-Naïve Participants - Low Weight Based Dosing
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1: ESA-Naïve Participants - Standard Weight Based Dosing
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1: ESA-Treated Participants - Low Weight Based Dosing
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1: ESA-Treated Participants - Standard Weight Based Dosing
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Roxadustat QW
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Roxadustat BIW
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Roxadustat TIW
Arm Type
Experimental
Arm Description
Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Other Intervention Name(s)
FG-4592
Intervention Description
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks
Time Frame
Weeks 1 to 20
Title
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
Title
Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits
Time Frame
Weeks 33 to 37
Secondary Outcome Measure Information:
Title
Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits
Time Frame
Baseline, Weeks 17 to 21
Title
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
Title
Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L
Time Frame
Weeks 33 to 37
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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.
Facility Information:
Facility Name
Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Investigational Site
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Investigational Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Investigational Site
City
Nanning
State/Province
Guangxi Province
ZIP/Postal Code
530021
Country
China
Facility Name
Investigational Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Investigational Site
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014010
Country
China
Facility Name
Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Investigational Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110122
Country
China
Facility Name
Investigational Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Investigational Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Investigational Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Investigational Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36005278
Citation
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Results Reference
derived
Learn more about this trial
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
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