Overview
Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation
Status:
Terminated
Terminated
Trial end date:
2014-04-01
2014-04-01
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mehrotra, Anita, M.D.Collaborator:
Icahn School of Medicine at Mount SinaiTreatments:
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)