Prevalence and Treatment of Anemia in Rehabilitation Patients

This study has been terminated.
(Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated)
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00511901
First received: August 3, 2007
Last updated: December 27, 2013
Last verified: November 2011
Results First Received: August 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: placebo
Drug: epoetin alpha
Drug: Niferex

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited at two subacute rehabilitation facilities in Central New Jersey between October 2005 and March 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo & Niferex Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
Epoetin Alpha & Niferex 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

Participant Flow:   Overall Study
    Placebo & Niferex     Epoetin Alpha & Niferex  
STARTED     11     11  
COMPLETED     10     8  
NOT COMPLETED     1     3  
Withdrawal by Subject                 1                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat

Reporting Groups
  Description
Placebo & Niferex Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
Epoetin Alpha & Niferex 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo & Niferex     Epoetin Alpha & Niferex     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  74.4  ± 8.3     75.5  ± 8.4     75.0  ± 8.2  
Gender  
[units: participants]
     
Female     10     8     18  
Male     1     3     4  
Race/Ethnicity, Customized  
[units: Participants]
     
White     9     10     19  
Black     2     1     3  
Hemoglobin Level [1]
[units: g/dL]
Mean ± Standard Deviation
  9.8  ± 1.0     9.8  ± 0.6     9.8  ± 0.8  
Days From Admit to Randomization [2]
[units: Days]
Mean ± Standard Deviation
  5.5  ± 1.5     5.3  ± 1.8     5.4  ± 1.6  
FIM Motor Scale [3]
[units: Scores on a Scale]
Mean ± Standard Deviation
  74.2  ± 8.8     68.8  ± 6.9     71.5  ± 8.2  
FACIT Fatigue Scale [4]
[units: Scores on a Scale]
Mean ± Standard Deviation
  31.6  ± 9.5     29.2  ± 11.6     30.4  ± 10.4  
POMS Depression-Dejection Scale [5]
[units: Scores on a Scale]
Median ( Inter-Quartile Range )
  3  
  ( 1 to 13 )  
  3  
  ( 0 to 8 )  
  3  
  ( 1 to 8 )  
[1] Level Prior to Randomization
[2] # of days from admission to the subacute rehabilitation facility to randomization into the study
[3] The Functional Independence Measure scale is a 7 point rating scale used as part of the Uniform Data System for Medical Rehabilitation. The FIM motor score ranges from 13 to 91 (most independent).
[4] FACIT-Fatigue Scale (version 4) 13 item questionnaire to assess level of fatigue. The FACIT-Fatigue scores range from 0 to 52(most fatigue).
[5] Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The POMS scores range from 0 to 60(most depressed).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study   [ Time Frame: 8 weeks following randomization ]

2.  Secondary:   Motor-FIM Score   [ Time Frame: 3, 8, and 12 weeks following randomization ]

3.  Secondary:   Length of Stay in Subacute Rehabilitation Facility   [ Time Frame: 12 weeks following randomization ]

4.  Secondary:   Grip Strength   [ Time Frame: 3, 8, and 12 weeks following randomization ]

5.  Secondary:   Short Physical Performance Battery (SPPB) Score   [ Time Frame: 3, 8, and 12 weeks following randomization ]

6.  Secondary:   FACIT Measurement System Fatigue Scale   [ Time Frame: 3, 8, and 12 weeks following randomization ]

7.  Secondary:   Activity Counts   [ Time Frame: 3, 8, and 12 weeks following randomization ]

8.  Secondary:   POMS Depression-Dejection Scale   [ Time Frame: 3,8,12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Jeffrey L Carson, MD
Organization: University of Medicine and Dentistry of New Jersey
phone: 732-235-7122
e-mail: carson@umdnj.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00511901     History of Changes
Other Study ID Numbers: 0220045106
Study First Received: August 3, 2007
Results First Received: August 27, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board