Status:
COMPLETED
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Lead Sponsor:
FibroGen
Collaborating Sponsors:
AstraZeneca
Astellas Pharma Inc
Conditions:
End Stage Renal Disease
Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treate...
Detailed Description
Dose ranging study with consecutive cohorts in two participant populations: participants normally responding to current anemia treatment (epoetin alfa) ("normoresponders": participants with baseline e...
Eligibility Criteria
Inclusion
- Key
- ESRD and receiving maintenance HD TIW for ≥4 months prior to Day 1
- Two most recent Hb values obtained during screening period must be within the ranges set below:
- i) Group A. Normoresponder Criteria: Hb range in the 8 weeks prior to randomization within 9.0 to 13.5 g/dL ii) Group B. Hyporesponder Criteria: Hb range in the 8 weeks prior to randomization within 8.5 to 13.5 g/dL
- Epoetin alfa, dose requirements:
- i) Group A. Normoresponder Criteria - Cohorts A-1 to A-12: Stable IV epoetin alfa dose at baseline (that is, no more than a 30% fluctuation in the weekly dose) during the 4 weeks prior to study Day -3
- Cohorts A-1 to A-4: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 85 IU/kg/dose, TIW; weekly dose between 75 and 255 IU/kg/week
- Cohort A-5: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 115 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
- Cohort A-9: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 150 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
- Cohorts A-6 to A-8: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 115 IU/kg/dose, TIW, and two times a week (BIW); total weekly dose between 75 and 345 IU/kg/week
- Cohorts A-10 to A-12: Optional cohorts to be decided (TBD), dosing frequency and dose range to be determined by sponsor ii) Group B. Hyporesponder Criteria:
- <!-- -->
- Cohort B-1 (completed): Current and previous (past 4 weeks) epoetin alfa dose range 125 to 400 IU/kg/dose, TIW; weekly dose between 375 and 1200 IU/kg/week
- Cohort B-2 to B-4: Current and previous (past 4 weeks) epoetin alfa dose range \>115 IU/kg/dose, TIW; total weekly dose \>345 IU/kg/week no requirement for stability of epoetin alfa doses
- Complete Blood Count (CBC), Hematology, liver function blood tests, serum folate and vitamin B12 within acceptable limits
- Absence of active or chronic gastrointestinal bleeding
- High sensitivity C-reactive protein (hsCRP) \<60 mg/liter for normoresponders Cohorts A-8 through A-12 enrolled under Amendment 3; no hsCRP criteria for hyporesponders
- Body weight: 40 to 140 kg (dry weight)
- Body mass index (BMI): 18 to 45 kg/meter square (m\^2)
- Dialysis vascular access via native arteriovenous fistula or synthetic graft, or permanent (tunneled) catheter (not via temporary catheter); permanent and temporary catheters, however, are still prohibited in Cohort A-5
- Key
Exclusion
- Anticipated change in HD prescription
- Any clinically significant infection or evidence of an underlying infection
- Positive for any of the following: Human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- New York Heart Association Class III or IV congestive heart failure
- Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- History of myelodysplastic syndrome
- History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
- Active hemolysis or diagnosis of hemolytic syndrome
- Known bone marrow fibrosis
- Uncontrolled or symptomatic secondary hyperparathyroidism
- Any prior organ transplantation
- Drug-treated gastroparesis or short-bowel syndrome
- History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the participant
- Prior treatment with roxadustat
- Diagnosis or suspicion of renal cell carcinoma
- Red blood cell (RBC) transfusion within 12 weeks prior to Day 1, or anticipated need for RBC transfusion during the dosing period
- IV iron supplement within 2 weeks prior to Day 1 and/or unwilling to withhold IV iron during the dosing/treatment period
Key Trial Info
Start Date :
May 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2012
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01147666
Start Date
May 17 2010
End Date
October 15 2012
Last Update
January 11 2022
Active Locations (25)
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1
Tempe, Arizona, United States
2
Pine Bluff, Arkansas, United States
3
Azusa, California, United States
4
Los Angeles, California, United States