Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin Alfa

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Epoetin alfa; 150 units/kg/week	Drug: Epoetin Alfa; 150 units/kg/weekly; Other Names: Procrit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in hemoglobin	The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment.	6 weeks to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
change in renal function (eGFR)	6 weeks to 1 year

Collaborators and Investigators

• Sponsor: Mehrotra, Anita, M.D.
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Study Director: Anita Mehrotra, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: anemia; kidney transplant; alloimmunity
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 10-0843; EPONAP2001 (Other Grant/Funding Number: Centocor Ortho Biotech)