Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
NCT ID: NCT00761657
Last Updated: 2021-11-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2006-11-01
2010-06-21
Brief Summary
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Detailed Description
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On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study until evaluation of a report of a death due to fulminant hepatic failure in a participant with CKD in a FibroGen-sponsored clinical trial of another hypoxia inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) (FG-2216) being investigated for treatment of anemia in participants with CKD and other diseases. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Roxadustat 0.7 mg/kg BIW
Participants will receive roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat
Capsule
Roxadustat 0.7 mg/kg TIW
Participants will receive roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Roxadustat
Capsule
Roxadustat 1.0 mg/kg BIW
Participants will receive roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
Roxadustat
Capsule
Roxadustat 1.0 mg/kg TIW
Participants will receive roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
Roxadustat
Capsule
Roxadustat 1.5 mg/kg BIW
Participants will receive roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat
Capsule
Roxadustat 1.5 mg/kg TIW
Participants will receive roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Roxadustat
Capsule
Roxadustat 2.0 mg/kg BIW
Participants will receive roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat
Capsule
Roxadustat 2.0 mg/kg TIW
Participants will receive roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Roxadustat
Capsule
Placebo
Participants will receive placebo orally, matching to the roxadustat dose, number of days per week, and duration.
Placebo
Capsule
Interventions
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Roxadustat
Capsule
Placebo
Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic Kidney Disease Stage 3 or 4 with hemoglobin \<11.0 grams (g)/deciliter (dL).
3. Normal iron studies.
4. Normal folate and vitamin B12 levels.
5. Liver function tests within normal limits at screening.
6. Absence of active or chronic rectal bleeding.
7. Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
8. Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
9. Male participants with partners who can have children must agree to use a medically acceptable method of contraception.
Exclusion Criteria
2. History of chronic liver disease.
3. History of polycystic kidney disease (PKD).
4. Uncontrolled hypertension (diastolic BP \>110 millimeter of mercury (mmHg) or systolic BP \>170 mmHg at screening).
5. New York Heart Association Class III or IV congestive heart failure.
6. Recent myocardial infarction or acute coronary syndrome.
7. History of myelodysplastic syndrome.
8. Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
9. Active inflammatory infection or chronic inflammatory disease.
10. Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
11. Blood clots within 4 weeks.
12. History of ongoing hemolysis or diagnosis of hemolytic syndrome.
13. Known history of bone marrow fibrosis.
14. History of hemosiderosis or hemochromatosis.
15. Androgen therapy within 12 weeks.
16. Red blood cell transfusion within 12 weeks.
17. Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
18. Intravenous iron supplementation within the past 60 days.
19. Currently taking dapsone or acetaminophen \>2.6 g/day.
20. History of prior organ transplantation.
21. Alcohol consumption greater than 3 or more drinks per day within the past year.
22. Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
23. Positive urine toxicology screen for a substance that has not been prescribed for the participant.
18 Years
80 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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Peoria, Arizona, United States
Tempe, Arizona, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Sacramento, California, United States
San Diego, California, United States
Whittier, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Middlebury, Connecticut, United States
Ocala, Florida, United States
Panama City, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Evergreen Park, Illinois, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Detroit, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Flushing, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Medford, Oregon, United States
Wynnewood, Pennsylvania, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
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.
Besarab A, Provenzano R, Hertel J, Zabaneh R, Klaus SJ, Lee T, Leong R, Hemmerich S, Yu KH, Neff TB. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrol Dial Transplant. 2015 Oct;30(10):1665-73. doi: 10.1093/ndt/gfv302. Epub 2015 Aug 3.
Other Identifiers
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FGCL-SM4592-017
Identifier Type: -
Identifier Source: org_study_id