Evaluation of Efficacy and Safety of Roxadustat in the Treatment of Anemia in Stable Dialysis Subjects



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 2014
End Date:September 19, 2018

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A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis

The purpose of this study is to determine whether roxadustat is effective and safe compared
to epoetin alfa in the maintenance treatment of anemia in stable hemodialysis and peritoneal
dialysis subjects when converted from their existing stable erythropoiesis stimulating agent
treatment.

Amendment 1: The primary purpose of this amendment is to evaluate safety and efficacy of
roxadustat compared to epoetin-alfa in newly initiated (incident) dialysis subjects who have
been on ESA (≥ 4 weeks) for treatment of anemia prior to screening

This study will consist of three study periods as follows:

1. Screening Period of up to 6 weeks (8 weeks if on Mircera)

2. Treatment Period: a minimum of 52 weeks, a maximum of up to 3 years.

3. A Follow-up period of 4 weeks.

A total of up to 820 patients will be randomized in a 1:1 ratio to receive either roxadustat
or Epoetin alfa (Active Control) in an open-label manner.

Under Amendment 1, approximately 150 incident dialysis subjects will be randomized to either
roxadustat or epoetin alfa (active control) in a 1:1 ratio

Inclusion Criteria:

- Subject age ≥ 18 years

- Subject receiving adequate dialysis using the same modality of dialysis for end-stage
renal disease for ≥ 3 months prior to and during screening.

Amendment 1 Only: Incident dialysis subjects receiving dialysis for native kidney ESRD for
≥ 2 weeks but ≤ 4 months at the time of randomization

- Subject is receiving IV or SC ESA for ≥ 8 weeks prior to screening and on a stable ESA
(≤30% change) dose during 4 weeks ( 8 weeks if on Mircera) prior to randomization.

Amendment 1 Only: Incident dialysis subjects must be on ESA for ≥ 4 weeks prior to
screening

- Mean of subject's 3 most recent Hb values must be ≥ 9.0 g/dL and ≤ 12.0 g/dL; with an
absolute difference of ≤ 1.3 g/dL between the highest and the lowest value.

Amendment 1 Only: For Incident dialysis subjects, mean of the three most recent central lab
Hb values during the Screening Period must be ≥ 8.5 g/dL and ≤12.0 g/dL

- Subject has a ferritin level of ≥ 100 ng/mL at screening

- Subject has a transferrin saturation (TSAT) level be ≥ 20% at screening

- Subject has a serum folate level ≥ lower limit of normal (LLN), Vitamin B12 level ≥
LLN

- Subject's ALT and AST are ≤ 3x the upper limit of normal (ULN), and TBL is ≤ 1.5x ULN
at screening

- Subject's body weight 45 kg to 160 kg.

Exclusion Criteria:

- Subject received an RBC transfusion within 8 weeks prior to randomization

- Subject has known history of myelodysplastic syndrome or multiple myeloma

- Subject has known inherited disease such as thalassemia or sickle cell anemia or other
known causes for anemia other than chronic kidney disease.

- Subject has known hemosiderosis, hemochromatosis, coagulation disorder,or
hypercoagulable condition

- Subject has known chronic inflammatory disease that could cause anemia

- Subject has anticipated surgery that is expected to cause blood loss

- Subject has known gastrointestinal bleeding

- Subject has history of chronic liver disease (eg,chronic infectious hepatitis,chronic
auto-immune liver disease,cirrhosis, or fibrosis of the liver)

- Subject has congestive heart failure (NYHA Class III or IV)

- Subject has had a heart attack, stroke, seizure, or a thrombotic/thromboembolic event
(eg, DVT or pulmonary embolism) within 12 weeks prior to participating in the study

- Subject has uncontrolled high blood pressure within 2 weeks prior to participating in
the study

- Subject has a history of malignancy, except for the following: cancers determined to
be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell
skin cancers, cervical cancer in situ, or resected colonic polyps.)

- Subject is positive for human immunodeficiency virus (HIV), Hepatitis B surface
antigen, or anti-hepatitis C virus antibody

- Subject has had any prior organ transplant (that has not been explanted)

- Subject has any of the following known untreated conditions; proliferative diabetic
retinopathy,diabetic macular edema,macular degeneration or retinal vein occlusion.
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Pembroke Pines, Florida 33028
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5766 Trumbull Avenue
Detroit, Michigan 48236
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Durham, North Carolina 27704
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Edinburg, Texas 78539
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3034 Sandage Avenue
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