Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

Anemia has become an increasingly recognized problem in kidney transplant recipients, and
erythropoietin is often prescribed as treatment despite limited data regarding outcomes.
Multiple clinical trials have demonstrated correction of anemia with erythropoietin in
patients with chronic kidney disease (pre-transplant) and patients on dialysis. No large
clinical trials of erythropoietin treatment have been done in anemic kidney transplant
recipients, however. The investigators hypothesize that when used for the treatment of
post-transplant anemia, Epoetin Alfa increases hemoglobin (Hb). The investigators further
hypothesize that Epoetin Alfa suppresses pathogenic alloimmunity directed at the kidney
transplant and as a consequence, prevents immune-mediated injury and thereby preserves renal
function. Finally, the investigators hypothesize that treatment of post-transplant anemia
with Epoetin Alfa also results in improved patient-reported outcomes (quality of life) and
decreased left ventricular mass. In order to test these hypotheses, the investigators
propose a randomized controlled trial of Epoetin Alfa in anemic kidney transplant recipients
(9.0 < Hb < 11.0). 100 study subjects will be randomized to either treatment with Epoetin
Alfa at a starting dose of 150 units/kg/week or no treatment (50 subjects/arm). The primary
outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year
of enrollment. Secondary outcomes to be measured include change in renal function (eGFR),
change in T cell phenotype, change in patient-reported outcomes (SF-36 form), and change in
left ventricular mass (by cardiac MRI).

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)