NCT00228995

Brief Summary

The purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (Hb \<= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRIT®) versus placebo.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

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

June 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

September 27, 2005

Last Update Submit

June 8, 2011

Conditions

AnemiaAgedHemoglobins

Keywords

AnemiaSubcutaneous injectionPROCRITErythropoietinEpoetin AlfaHemoglobin LevelElderly

Outcome Measures

Primary Outcomes (1)

  • To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.

Secondary Outcomes (1)

  • To assess: Efficacy of Procrit by achieving a target Hb of 12.5-12.9 g/dL; Change in FACT-An score; Change in Six-Minute Walk Test, Safety (Adverse Event incidence, Lab Tests, and Vitals); Cognitive function; Number and type of injuries from falls

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with a history of chronic anemia defined as a documented Hb value of \<= 11.0 g/dL
  • No active cancer
  • At least 65 years of age with life expectancy of \> 6 months
  • Community dwelling patients
  • Patients with a Short Physical Performance (SPPB) Summary Score of 4-10 at screening and baseline
  • Patients with a Mini Mental State Examination (MMSE) score \>= 24

You may not qualify if:

  • Positive stool guaiac test
  • Diagnosis of multiple myeloma and/or MGUS
  • History of venous thromboembolytic disease
  • Previous treatment with Epoetin alfa, Darbepoetin or any form of erythropoietin recently
  • Uncontrolled or severe cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

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

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

June 1, 2004

Study Completion

September 1, 2005

Last Updated

June 10, 2011

Record last verified: 2010-04