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

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

Sponsors

Lead sponsor: FibroGen

Source FibroGen
Brief Summary

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

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.

Overall Status Completed
Start Date December 2011
Completion Date January 2013
Primary Completion Date January 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximum change in hemoglobin by Week 9 from baseline Week 9
Secondary Outcome
Measure 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
Enrollment 91
Condition
Intervention

Intervention type: Drug

Intervention name: FG-4592

Description: TIW dosing, capsule

Arm group label: FG-4592

Intervention type: Drug

Intervention name: Placebo

Description: TIW dosing, capsule

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Age 18 to 75 years

2. Subject has voluntarily signed and dated an informed consent form

3. Chronic Kidney Disease, not receiving dialysis

4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL

5. Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period

6. 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

7. Total bilirubin values must be ≤ULN during screening period

8. Serum folate and vitamin B12 levels above the lower limit of normal (LLN)

9. Body weight: 40 to 100 kg (dry weight) inclusive

10. Body mass index (BMI): 16 to 38 kg/m2 inclusive

Exclusion Criteria:

1. Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1

2. 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,

3. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)

4. History of chronic liver disease

5. New York Heart Association Class III or IV congestive heart failure

6. 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

7. Active or chronic gastrointestinal bleeding, or a known coagulation disorder

8. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)

9. Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

10. History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric

11. Active hemolysis or diagnosis of hemolytic syndrome

12. Known bone marrow fibrosis

13. Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)

14. Any prior organ transplantation

15. Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug

16. Serum albumin <3 g/dL

17. History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject

18. Prior treatment with FG-4592

19. Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.

20. 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Location
facility
Peking Union Medical College Hospital | Beijing, China
Peking University First Hospital | Beijing, China
Sichuan Provincial People's Hospital | Chengdu, China
West China Hospital | Chengdu, China
First affiliated hospital of Dalian medical university | DaLian, China
First Affiliated Hospital, Sun Yat-Sen University | Guangzhou, China
Zhejiang University No 1. Hospital | Hangzhou, China
Chang Zheng Hospital | Shanghai, China
Huashan Hospital | Shanghai, China
Renji Hospital | Shanghai, China
RuiJin Hospital | Shanghai, China
XinHua Hospital | Shanghai, China
Shenzhen People's Hospital | Shenzhen, China
Location Countries

China

Verification Date

February 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: FG-4592

Arm group type: Experimental

Description: Active Drug

Arm group label: Placebo

Arm group type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov