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A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects with Chronic Kidney Disease Not Re

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What is the purpose of this trial?

Objectives: The primary objectives of this study are as follows: • To evaluate the safety and tolerability of a range of oral doses of FG-4592 administered two times weekly (BIW) or three times weekly (TIW) to subjects with CKD not requiring dialysis • To characterize the pharmacodynamic effects (PD) of a range of oral doses of FG-4592 administered two or three times weekly on hemoglobin response in subjects with CKD disease not requiring dialysis The secondary objectives of this study are as follows: • To characterize the trough concentrations of FG-4592 administered two or three times weekly (BIW or TIW) in subjects with CKD not requiring dialysis • To determine the PD effects of FG-4592 on biologic markers of erythropoiesis in subjects with CKD not requiring dialysis The exploratory objectives of this study are as follows: 􀂃 To characterize the effects of a range of oral doses of FG-4592 administered BIW or TIW on biomarkers associated with iron utilization and regulation, systemic inflammation, and vasculogenesis Study Design: This is a randomized, single-blind, placebo-controlled, parallel-arm study with cohort-based dose-escalation in anemic patients with Stage 3 or 4 CKD.

Date & Status

Recruiting

Eligibility1. Written informed consent 2. 18 to 70 years of age 3. Chronic kidney disease with an estimated glomerular filtration rate (eGFR) between 15 and 59 mL/min/1.73 m2 (Stages 3 and 4), as estimated by the simplified modification of diet in renal disease (MDRD) formula (as described by (Levey, 2003) 4. Median and final pretreatment (i.e., screening period) hemoglobin values ≤11.0 g/dL 5. None of the hemoglobin values obtained during the last three screening visits should differ by more than 1 g/dL from any other value 6. Serum transferrin saturation >20% and serum ferritin >100 ng/mL 7. Serum folate and vitamin B12 > lower limit of normal (LLN) 8. Median and final pretreatment (i.e., screening period) TBili within normal limits 9. Median and final pretreatment (i.e., screening period) aminotransferase (ALT and AST) levels within normal limits 10. Serum ALP < 2x ULN. However, subjects with ALP values between 1x and 2x ULN may be included if BSAP is also elevated 11. Absence of active or chronic bleeding, confirmed by negative fecal occult blood test (at screening) 12. 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, in the opinion of an ophthalmologist (confirmed by ophthalmologist in last 3 months) 13. If female, subjects must be: • Surgically sterile (hysterectomy or bilateral tubal ligation) or at least 2 years postmenopausal, or >55 years old • Neither pregnant nor breast-feeding and agree to use two forms of birth control during the trial and for a period of at least 12 weeks after completion of the study drug treatment 14. Male subjects with partners of childbearing potential must agree to use a medically acceptable method of contraception during the trial and for a period of at least 12 weeks after completion of the study drug treatment Exclusion Criteria 1. Seropositive for HIV 2. Seropositive for HBsAg, HCV Ab positive, or history of any other types of chronic liver disease 3. History of 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. Myocardial infarction or acute coronary syndrome within 3 months of Study Day 1 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 condition that could inhibit erythropoiesis (e.g., gout) 10. Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission 11. Clinical or laboratory evidence of active infection 12. Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study 13. Thromboembolic event within 4 weeks preceding Day 1 14. History of ongoing hemolysis or diagnosis of hemolytic syndrome 15. Known bone marrow fibrosis 16. History of hemosiderosis or hemochromatosis 17. Androgen therapy within 12 weeks prior to Day 1 18. Red blood cell transfusion within 12 weeks prior to Day 1 19. Therapy with an ESA within 60 days prior to Day 1 20. Intravenous iron supplementation within 60 days of Day 1 or unable to interrupt iron supplementation for the duration of the trial (NOTE: subjects on oral iron may be included; however, subjects must remain on stable dose of oral iron throughout the study) 21. Anticipated to require medications primarily metabolized by CYP2C8 isoenzymes during the treatment period: paclitaxel, toresemide, amodiaquine, repaglinide, carbamazepine, pioglitazone, and rosiglitazone 22. Anticipated to require dapsone or acetaminophen >2.6 g/day during the treatment period or posttreatment safety extension period 23. Any prior organ transplantation 24. Abuse of alcohol or drugs or known excess alcohol intake, defined as 3 or more alcohol-containing drinks per day (within the past year) 25. Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1 26. Positive urine toxicology screen
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Other Information

Trial ID: Study Drug: FG-4592
Volunteers:  Not Accepting Healthy Volunteers

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