Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The investigators hypothesize that epoetin alfa will raise hemoglobin.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mehrotra, Anita, M.D.
• Collaborator: Icahn School of Medicine at Mount Sinai
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. Age > 18 years

2. Kidney transplant recipient at least 8 weeks post-transplant

3. Mild to moderate anemia, defined as 9.0 g/dL < Hb < 11 g/dL)

4. Estimated GFR (by MDRD) < 60 mL/min (not on dialysis)

5. Transferrin saturation > 20% and Ferritin > 100 ng/mL

Exclusion Criteria:

1. History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks

2. Red blood cell transfusion in previous 30 days

3. History of HIV/AIDS

4. Nonfunctioning graft, defined as patient requiring chronic dialysis

5. Hypersensitivity to ESAs or albumin

6. Uncontrolled hypertension, defined as screening BP > 180/100

7. New-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication)

8. History of any neoplasm except: adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease-free for more than 5 years.

9. Pregnancy or lactating

10. Vitamin B12 deficiency (Vit B12 < 180 pg/mL)

11. Untreated folate deficiency (folate < 6.6 ng/mL)