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Prevalence and Treatment of Anemia in Rehabilitation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00511901
Recruitment Status : Terminated (Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated)
First Posted : August 6, 2007
Results First Posted : November 11, 2013
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: placebo
Drug: epoetin alpha
Drug: Niferex

  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

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 
Overall Participants Analyzed 
[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) 
[1] Level Prior to Randomization
Days From Admit to Randomization [1] 
[Units: Days]
Mean (Standard Deviation)
 5.5  (1.5)   5.3  (1.8)   5.4  (1.6) 
[1] # of days from admission to the subacute rehabilitation facility to randomization into the study
FIM Motor Scale [1] 
[Units: Scores on a Scale]
Mean (Standard Deviation)
 74.2  (8.8)   68.8  (6.9)   71.5  (8.2) 
[1] 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).
FACIT Fatigue Scale [1] 
[Units: Scores on a Scale]
Mean (Standard Deviation)
 31.6  (9.5)   29.2  (11.6)   30.4  (10.4) 
[1] FACIT-Fatigue Scale (version 4) 13 item questionnaire to assess level of fatigue. The FACIT-Fatigue scores range from 0 to 52(most fatigue).
POMS Depression-Dejection Scale [1] 
[Units: Scores on a Scale]
Median (Inter-Quartile Range)
 3 
 (1 to 13) 
 3 
 (0 to 8) 
 3 
 (1 to 8) 
[1] 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

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


  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


  More Information

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



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
First Submitted: August 3, 2007
First Posted: August 6, 2007
Results First Submitted: August 27, 2013
Results First Posted: November 11, 2013
Last Update Posted: January 31, 2014