Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Collaborators: Chang Zheng Hospital; First Affiliated Hospital of Zhejiang University; First Affiliated Hospital, Sun Yat-Sen University; Peking Union Medical College Hospital; Peking University First Hospital; RenJi Hospital; Ruijin Hospital; Shenzhen People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

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

2. Age 18 to 75 years

3. End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1

4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.

5. Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:

• Epoetin alfa dose range for 6 weeks prior to Day -7:

3000 to 20,000 IU/week

• Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)

6. Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits

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

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

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

10. HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)

Exclusion Criteria:

1. Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study

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

17. Prior treatment with FG-4592

18. 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