Study of FG-4592 in Subjects With Chronic Kidney Disease in China

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.

Detailed Description
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Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia

Conditions
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Anemia in Chronic Kidney Disease

Intervention / Treatment
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* Drug: FG-4592
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years Subject has voluntarily signed and dated an informed consent form Chronic Kidney Disease, not receiving dialysis Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period Serum alkaline phosphatase (ALP) ≤2x ULN during screening period. Subjects with serum ALP values between 1 x and 2 x ULN may be included only if bone-specific ALP (BSAP) is also elevated > ULN Total bilirubin values must be ≤ULN during screening period Serum folate and vitamin B12 levels above the lower limit of normal (LLN) Body weight: 40 to 100 kg (dry weight) inclusive Body mass index (BMI): 16 to 38 kg/m2 inclusive Exclusion Criteria: Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1 Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions, Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); 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 other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission Active or chronic gastrointestinal bleeding, or a known coagulation disorder Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.) Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia 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 (PTH>600ng/L) Any prior organ transplantation Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug Serum albumin <3 g/dL History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject Prior treatment with FG-4592 Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period. Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FG-4592<br>Active Drug | Drug: FG-4592<br>* TIW dosing, capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* TIW dosing, capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change in hemoglobin by Week 9 from baseline |  | Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9. |  | Week 9 | 
| Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL. |  | Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Renal