Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
NCT ID: NCT01244763
Last Updated: 2022-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2010-10-29
2012-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Roxadustat Tiered, Weight Based Dosing TIW
Participants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kilograms (kg)\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
Roxadustat
Oral capsule
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW
Participants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.
Roxadustat
Oral capsule
Cohort C: Roxadustat at 50 mg TIW
Participants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
Roxadustat
Oral capsule
Cohort D: Roxadustat at 100 mg TIW
Participants will receive roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
Roxadustat
Oral capsule
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QW
Participants will receive roxadustat capsules for 24 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 70, 100, and 150 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.
Roxadustat
Oral capsule
Cohort F: Roxadustat at 70 mg BIW then QW
Participants will receive roxadustat capsules at 70 mg for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency will be reduced from BIW to QW.
Roxadustat
Oral capsule
Interventions
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Roxadustat
Oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic kidney disease, not receiving dialysis
3. Body weight 45 to 140 kg
Exclusion Criteria
2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
3. History of chronic liver disease
4. New York Heart Association Class III or IV congestive heart failure
5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
6. History of malignancy
7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
9. History of hemosiderosis, hemochromatosis or polycystic kidney disease
10. Active hemolysis or diagnosis of hemolytic syndrome
11. Uncontrolled or symptomatic secondary hyperparathyroidism
12. Seizure disorder or receiving anti-epilepsy medication
13. Known bone marrow fibrosis
14. Any prior or scheduled organ transplant
15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
16. History of alcohol or drug abuse
18 Years
75 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
FibroGen
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
Pine Bluff, Arkansas, United States
Azusa, California, United States
Chula Vista, California, United States
Downey, California, United States
Northridge, California, United States
Paramount, California, United States
Riverside, California, United States
Whittier, California, United States
Yuba City, California, United States
Fort Lauderdale, Florida, United States
Lauderdale Lakes, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Meridian, Idaho, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Bethesda, Maryland, United States
Detroit, Michigan, United States
Lincoln, Nebraska, United States
Mount Laurel, New Jersey, United States
Mineola, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
Canton, Ohio, United States
Orangeburg, South Carolina, United States
Knoxville, Tennessee, United States
Arlington, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Caguas, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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FGCL-4592-041
Identifier Type: -
Identifier Source: org_study_id
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