Clinical trial NCT01290328: Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation
Official title: Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anemia
Keywords: anemia
kidney transplant
alloimmunity
Lead sponsor: Mehrotra, Anita, M.D.
Sponsor class: INDIV
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2011-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility 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)

Primary outcomes:
measure: change in hemoglobin
timeFrame: 6 weeks to 1 year
Secondary outcomes:
measure: change in renal function (eGFR)
timeFrame: 6 weeks to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Anita Mehrotra, MD
role: STUDY_DIRECTOR
References: