Phase 2 Study of FG-4592 in Subjects With Anemia and Chronic Kidney Disease Not Requiring Dialysis

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the safety, tolerability and pharmacodynamic effects of 5 different oral doses of FG-4592 administered two times or three times weekly for up to 4 weeks to subjects with Chronic Kidney Disease not requiring dialysis.

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

Details

• Lead Sponsor: FibroGen
• Treatments: Glycine

Criteria

Inclusion Criteria:

1. 18 to 75 years of age.

2. Chronic Kidney Disease stage 3 or 4 with hemoglobin < 11.0 g/dL

3. Normal iron studies.

4. Normal folate and vitamin B12 levels.

5. Liver function tests within normal limits at screening.

6. Absence of active or chronic rectal bleeding.

7. Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema or diabetic proliferative retinopathy that is likely to require treatment during the trial.

8. Female subjects must not be pregnant nor breast-feeding.

9. Male subjects with partners who can have children must agree to use a medically acceptable method of contraception.

Exclusion Criteria:

1. Seropositive for HIV.

2. History of chronic liver disease.

3. History of polycystic kidney disease (PKD).

4. Uncontrolled hypertension (diastolic BP >110 mm Hg or systolic BP >170 mm Hg at screening).

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

6. Recent myocardial infarction or acute coronary syndrome.

7. History of myelodysplastic syndrome.

8. Any history of malignancy or a known genetic predisposition for developing cancer (e.g., with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.

9. Active inflammatory infection or chronic inflammatory disease

10. Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.

11. Blood clots within 4 weeks.

12. History of ongoing hemolysis or diagnosis of hemolytic syndrome.

13. Known history of bone marrow fibrosis.

14. History of hemosiderosis or hemochromatosis.

15. Androgen therapy within 12 weeks.

16. Red blood cell transfusion within 12 weeks.

17. Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.

18. Intravenous iron supplementation within the past 60 days.

19. Currently taking acetaminophen >2.6 g/day.

20. History of prior organ transplantation.

21. Alcohol consumption greater than 3 or more drinks per day within the past year.

22. Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.

23. Positive urine toxicology screen for a substance that has not been prescribed for the subject.

For subjects aged over 75 years but who otherwise meet all other patient selection criteria, subjects will be evaluated on a case-by-case basis and can be included in this study, per discretion of sponsor's physician representative such as medical monitor or clinical leader.