Study of FG-4592 in Non-Dialysis Chronic Kidney Disease Patients With Anemia

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: FibroGen

Criteria

Inclusion Criteria:

1. Age 18 to 75 years

2. Chronic kidney disease, not receiving dialysis

3. Body weight 45 to 140 kg

Exclusion Criteria:

1. Any clinically significant infection or evidence of an underlying infection

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

3. History of chronic liver disease

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

5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization

6. History of malignancy

7. Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission

8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

9. History of hemosiderosis, hemochromatosis or polycystic kidney disease

10. Active hemolysis or diagnosis of hemolytic syndrome

11. Uncontrolled or symptomatic secondary hyperparathyroidism

12. Seizure disorder or receiving anti-epilepsy medication

13. Known bone marrow fibrosis

14. Any prior or scheduled organ transplant

15. Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor

16. History of alcohol or drug abuse