A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00337935
First received: June 16, 2006
Last updated: May 7, 2013
Last verified: May 2013
Results First Received: July 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Failure , Chronic
Anemia
Interventions: Drug: Epoetin Alfa
Other: Standard of care

  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
No text entered.

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
Standard of Care Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
PROCRIT (Epoetin Alfa) epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks

Participant Flow:   Overall Study
    Standard of Care     PROCRIT (Epoetin Alfa)  
STARTED     39     118  
COMPLETED     29     91  
NOT COMPLETED     10     27  
Adverse Event                 2                 5  
Death                 2                 8  
Physician Decision                 1                 1  
Lost to Follow-up                 0                 1  
Protocol Violation                 4                 3  
Withdrawal by Subject                 1                 7  
Unknown                 0                 1  
Lack of Efficacy                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Standard of Care Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
PROCRIT (Epoetin Alfa) epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Total Total of all reporting groups

Baseline Measures
    Standard of Care     PROCRIT (Epoetin Alfa)     Total  
Number of Participants  
[units: participants]
  39     118     157  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     4     6  
>=65 years     37     114     151  
Age  
[units: Years]
Mean ± Standard Deviation
  84.4  ± 10.9     84.1  ± 9.2     84.1  ± 9.6  
Gender  
[units: participants]
     
Female     33     90     123  
Male     6     28     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)   [ Time Frame: Week 0 to Week 26 ]

2.  Secondary:   The Number of Patients Achieved a Hemoglobin Response.   [ Time Frame: Week 0 to Week 26 ]

3.  Secondary:   Time to Hemoglobin Response   [ Time Frame: Week 0 to Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Vice President, Medical Affairs
Organization: Centocor Ortho-Biotech LLC.
phone: 800.457.6399


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00337935     History of Changes
Other Study ID Numbers: CR012229
Study First Received: June 16, 2006
Results First Received: July 16, 2010
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration