Prevalence and Treatment of Anemia in Rehabilitation Patients

NCT00511901 | Terminated Phase 4 Results DMC

• 1 other identifier: 0220045106
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Patients who are admitted to subacute rehabilitation facilities following hospitalization are frequently anemic. The purpose of this study is to see if anemic patients treated with epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and 12 weeks after study entry compared to patients who do not receive epoetin alfa.

Conditions

Anemia

Keywords

anemia; function; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study

  8 weeks following randomization

Secondary Outcomes (7)

• Motor-FIM Score

  3, 8, and 12 weeks following randomization

• Length of Stay in Subacute Rehabilitation Facility

  12 weeks following randomization

• Grip Strength

  3, 8, and 12 weeks following randomization

• Short Physical Performance Battery (SPPB) Score

  3, 8, and 12 weeks following randomization

• FACIT Measurement System Fatigue Scale

  3, 8, and 12 weeks following randomization

Study Arms (2)

Placebo & Niferex

PLACEBO COMPARATOR

Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

Drug: placebo; Drug: Niferex

epoetin alpha & Niferex

ACTIVE COMPARATOR

40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

Drug: epoetin alpha; Drug: Niferex

Interventions

placebo DRUG

Placebo & Niferex

epoetin alpha DRUG

Also known as: Procrit

epoetin alpha & Niferex

Niferex DRUG

Also known as: iron polysaccharide

Placebo & Niferex; epoetin alpha & Niferex

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Admission hemoglobin concentration of \< 10.5 g/dL.
• Able to read and understand English.
• Consent signed by subjects.

You may not qualify if:

• Unable to randomize within 7 days of admission to rehabilitation center.
• Folstein min-mental status score of \< 21.
• Neuromuscular disease and/or disability; in clinical judgment of the investigators that do not have rehabilitation potential.
• Diagnosis or evidence of carcinoma (excluding skin cancer other than melanoma) within the past five years
• Admission for stroke with residual deficit
• Wheelchair bound prior to acute event.
• Dialysis dependent chronic renal failure
• Home more than 1 hour drive from hospital.
• Admitted to long term nursing or hospice care.
• Active blood loss.
• Known history of severe iron deficiency.
• Hematological disease that results in anemia that may not respond to erythropoietin (including, but not limited to, myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy).
• Uncontrolled hypertension (systolic BP \>200 mmHg or diastolic BP \>110 mmHg) after adequate antihypertensive therapy.
• New onset seizures (within three months) or seizures not controlled by medication.
• Objective diagnosis of pulmonary embolism or deep vein thrombosis within the past 10 years.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

Study Sites (2)

Elms of Cranbury

Cranbury, New Jersey, 08512, United States

Location

Care One East Brunswick

East Brunswick, New Jersey, 08816, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa; Niferex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Limited number of eligible subjects, burdensome protocol requirements impeded recruitment, controversy concerning safety of epoetin alpha which led to early termination of study

Results Point of Contact

• Title: Jeffrey L Carson, MD
• Organization: University of Medicine and Dentistry of New Jersey

carson@umdnj.edu

732-235-7122

Study Officials

• Jeffrey L Carson, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: November 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 31, 2014
• Results First Posted: November 11, 2013

Record last verified: 2011-11

Locations

US (2)