Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01290328
• Other study ID #: 10-0843
• Secondary ID: EPONAP2001
• Status: Terminated
• Phase: N/A
• First received: February 3, 2011
• Last updated: February 26, 2014
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2012
• Source: Mehrotra, Anita, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin Alfa
150 units/kg/weekly

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mehrotra, Anita, M.D.	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in renal function (eGFR)		6 weeks to 1 year	No