Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

Stopped early · Not applicable

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT01290328

Run by

Mehrotra, Anita, M.D.

People needed

100

Starts

2011-02-01

Expected to finish

2014-04-01

Last updated by the study team

2014-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Kidney transplant recipient at least 8 weeks post-transplant
• Mild to moderate anemia, defined as 9.0 g/dL < Hb < 11 g/dL)
• Estimated GFR (by MDRD) < 60 mL/min (not on dialysis)
• Transferrin saturation > 20% and Ferritin > 100 ng/mL

You may not qualify if…

• History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks
• Red blood cell transfusion in previous 30 days
• History of HIV/AIDS
• Nonfunctioning graft, defined as patient requiring chronic dialysis
• Hypersensitivity to ESAs or albumin
• Uncontrolled hypertension, defined as screening BP > 180/100
• New-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication)
• 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.
• Pregnancy or lactating
• Vitamin B12 deficiency (Vit B12 < 180 pg/mL)
• Untreated folate deficiency (folate < 6.6 ng/mL)

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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