Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation

NCT ID: NCT01290328

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-04-30

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).

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Epoetin alfa

150 units/kg/week

Group Type: EXPERIMENTAL

Epoetin Alfa

Intervention Type: DRUG

150 units/kg/weekly

Interventions

Epoetin Alfa

150 units/kg/weekly

Intervention Type: DRUG

Other Intervention Names

Procrit

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Mehrotra, Anita, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Anita Mehrotra MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Mehrotra, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

Other Identifiers

EPONAP2001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-0843

Identifier Type: -

Identifier Source: org_study_id