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An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00440557
First received: February 26, 2007
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: February 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: Epoetin alfa 3 times weekly /once weekly
Drug: Epoetin alfa once weekly
Drug: Epoetin alfa once every two weeks

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was initiated 29 August 2006 and completed on 21 February 2008. Subjects were screened for eligibility at 64 investigative sites within the U.S. Three hundred seventy-five subjects (intent to treat) were randomly assigned to a treatment group by 52 investigators from 56 sites. Safety population consisted of 373 subjects.

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
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW) Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
Epoetin Alfa:Once Weekly (QW) Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
Epoetin Alfa:Once Every Two Weeks (Q2W) Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)

Participant Flow:   Overall Study
    Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)     Epoetin Alfa:Once Weekly (QW)     Epoetin Alfa:Once Every Two Weeks (Q2W)  
STARTED     123 [1]   125 [1]   125 [1]
COMPLETED     98     96     90  
NOT COMPLETED     25     29     35  
Withdrawal by Subject                 10                 5                 11  
Lost to Follow-up                 1                 2                 6  
Adverse Event                 3                 3                 5  
Death                 2                 6                 3  
Began Dialysis                 4                 1                 4  
Principal Investigator decision                 0                 3                 1  
Patient moved                 1                 2                 1  
Principal Investigator's office closed                 3                 6                 4  
Patient transferred to nursing home                 0                 1                 0  
Patient had surgery                 1                 0                 0  
[1] Safety population defined as all subjects who received at least 1 injection of study drug.



  Baseline Characteristics
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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
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW) Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
Epoetin Alfa:Once Weekly (QW) Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
Epoetin Alfa:Once Every Two Weeks (Q2W) Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
Total Total of all reporting groups

Baseline Measures
    Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)     Epoetin Alfa:Once Weekly (QW)     Epoetin Alfa:Once Every Two Weeks (Q2W)     Total  
Number of Participants  
[units: participants]
  123     125     125     373  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     33     43     44     120  
>=65 years     90     82     81     253  
Age  
[units: years]
Mean ± Standard Deviation
  71.1  ± 13.02     68.9  ± 11.86     68.9  ± 13.02     69.6  ± 12.65  
Gender  
[units: participants]
       
Female     77     80     85     242  
Male     46     45     40     131  



  Outcome Measures
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1.  Primary:   Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22   [ Time Frame: From baseline through Week 22 ]

2.  Secondary:   Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9   [ Time Frame: From baseline to Week 9 ]

3.  Other Pre-specified:   Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]

4.  Other Pre-specified:   Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]

5.  Other Pre-specified:   Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]

6.  Other Pre-specified:   Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]

7.  Other Pre-specified:   Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]

8.  Post-Hoc:   Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment   [ Time Frame: From baseline to Week 22 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr Director of Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 908-927-2116 ext NA


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00440557     History of Changes
Other Study ID Numbers: CR010411, EPOAKD3001
Study First Received: February 26, 2007
Results First Received: February 23, 2009
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration