A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF ROXADUSTAT (FG-4592) FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1.Age > 18 years
2.Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines
3.Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation
4.Mean of the three most recent Hb values during the Screening Period, obtained at least 4 days apart, must be ≤10.0 g/dL, with a difference of ≤1.0 g/dL between the highest and the lowest values. The last screening Hb value must be within 10 days prior to randomization
5.Ferritin >30 ng/mL
6.TSAT >5%
7.Serum folate level ≥ lower limit of normal (LLN)
8.Serum vitamin B12 level ≥ lower limit of normal (LLN).
9.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN), and total bilirubin (Tbili) <1.5 x ULN
10.Body weight 45 to 160 kg

Exclusion Criteria

1.Any ESA treatment within 12 weeks prior to randomization
2.More than one dose of IV iron within 12 weeks prior to randomization
3.RBC transfusion within 8 weeks prior to randomization
4.Active, clinically significant infection that could be manifested by white blood cell (WBC) count >ULN, and/or fever, in conjunction with clinical signs or symptoms of infection
5.History of chronic liver disease (e.g. chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver)
6.New York Heart Association Class III or IV congestive heart failure
7.Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
8.Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeat measurement) within 2 weeks prior to randomization
9.Diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization
10.History of malignancy, except 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
11.Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
12.Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission
13.Known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion
14.Known history of myelodysplastic syndrome or multiple myeloma
15.Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD
16.Known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition
17.Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation
18.Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective coronary revascularization
19.Known active or chronic gastrointestinal bleeding
20.Any prior treatment with FG-4592 or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
21.Use of iron-chelating agents within 4 weeks prior to randomization
22.Use of an investigational drug or treatment, participation in an investigational study, or presence of expected carryover effect of an investigational treatment, within 4 weeks prior to randomization
23.Anticipated use of dapsone in any dose amount or anticipated chronic use of acetaminophen or paracetamol >2.0 g/day during the treatment or follow-up periods of the study
24.History of alcohol or drug abuse within 2 years prior to randomization
25.Females of childbearing potential, unless using contraception as detailed in the protocol, or sexual abstinence; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception or sexual abstinence
26.Pregnant or breastfeeding females
27.Any medical condition that in the opinion of the investigator may

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 1/11/2021

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF ROXADUSTAT (FG-4592) FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS

Recruitment & Eligibility

Study & Design

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