Status:
COMPLETED
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
Lead Sponsor:
FibroGen
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Chronic Kidney Disease
Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) ...
Detailed Description
This study in participants with CKD not requiring dialysis was conducted in 2 parts (designated Part 1 and Part 2). Part 1 evaluated roxadustat doses at 1.0 and 2.0 milligrams/kilograms (mg/kg). Part ...
Eligibility Criteria
Inclusion
- 18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
- Chronic Kidney Disease Stage 3 or 4 with hemoglobin \<11.0 grams (g)/deciliter (dL).
- Normal iron studies.
- Normal folate and vitamin B12 levels.
- Liver function tests within normal limits at screening.
- Absence of active or chronic rectal bleeding.
- 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.
- Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
- Male participants with partners who can have children must agree to use a medically acceptable method of contraception.
Exclusion
- Seropositive for HIV.
- History of chronic liver disease.
- History of polycystic kidney disease (PKD).
- Uncontrolled hypertension (diastolic BP \>110 millimeter of mercury (mmHg) or systolic BP \>170 mmHg at screening).
- New York Heart Association Class III or IV congestive heart failure.
- Recent myocardial infarction or acute coronary syndrome.
- History of myelodysplastic syndrome.
- 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.
- Active inflammatory infection or chronic inflammatory disease.
- Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
- Blood clots within 4 weeks.
- History of ongoing hemolysis or diagnosis of hemolytic syndrome.
- Known history of bone marrow fibrosis.
- History of hemosiderosis or hemochromatosis.
- Androgen therapy within 12 weeks.
- Red blood cell transfusion within 12 weeks.
- Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
- Intravenous iron supplementation within the past 60 days.
- Currently taking dapsone or acetaminophen \>2.6 g/day.
- History of prior organ transplantation.
- Alcohol consumption greater than 3 or more drinks per day within the past year.
- Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
- Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2010
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00761657
Start Date
November 1 2006
End Date
June 21 2010
Last Update
November 19 2021
Active Locations (34)
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1
Peoria, Arizona, United States, 85381
2
Tempe, Arizona, United States, 85284
3
Los Angeles, California, United States, 90095
4
Mission Viejo, California, United States, 92691