NCT01290328

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

February 3, 2011

Last Update Submit

February 26, 2014

Conditions

Anemia

Keywords

anemiakidney transplantalloimmunity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • change in renal function (eGFR)

    6 weeks to 1 year

Study Arms (2)

Standard of care

NO INTERVENTION

Epoetin alfa

EXPERIMENTAL

150 units/kg/week

Drug: Epoetin Alfa

Interventions

Epoetin AlfaDRUG

150 units/kg/weekly

Also known as: Procrit
Epoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Kidney transplant recipient at least 8 weeks post-transplant
  • Mild to moderate anemia, defined as 9.0 g/dL \< Hb \< 11 g/dL)
  • Estimated GFR (by MDRD) \< 60 mL/min (not on dialysis)
  • Transferrin saturation \> 20% and Ferritin \> 100 ng/mL

You may not qualify if:

  • History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks
  • Red blood cell transfusion in previous 30 days
  • History of HIV/AIDS
  • Nonfunctioning graft, defined as patient requiring chronic dialysis
  • Hypersensitivity to ESAs or albumin
  • Uncontrolled hypertension, defined as screening BP \> 180/100
  • New-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication)
  • 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.
  • Pregnancy or lactating
  • Vitamin B12 deficiency (Vit B12 \< 180 pg/mL)
  • Untreated folate deficiency (folate \< 6.6 ng/mL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Anita Mehrotra, MD

    Icahn School of Medicine at Mount Sinai

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

February 27, 2014

Record last verified: 2012-07

Locations

US(1)