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PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00440466
First received: February 26, 2007
Last updated: May 18, 2011
Last verified: March 2011
History of Changes
Results First Received: May 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anemia
Renal Diseases
Intervention: Drug: epoetin alfa

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Epoetin Alfa QW Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Epoetin Alfa Q2W Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Epoetin Alfa Q4W Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Participant Flow:   Overall Study
    Epoetin Alfa QW     Epoetin Alfa Q2W     Epoetin Alfa Q4W  
STARTED     108     107     215  
COMPLETED     95     92     174  
NOT COMPLETED     13     15     41  
Death                 3                 2                 9  
Adverse Event                 3                 4                 11  
Lost to Follow-up                 1                 0                 2  
Physician Decision                 2                 0                 1  
Protocol Violation                 2                 0                 4  
Withdrawal by Subject                 2                 5                 9  
Began Dialysis                 0                 0                 1  
Met Hemoglobin Withdrawal Criteria                 0                 4                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Epoetin Alfa QW Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Epoetin Alfa Q2W Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Epoetin Alfa Q4W Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Total Total of all reporting groups

Baseline Measures
    Epoetin Alfa QW     Epoetin Alfa Q2W     Epoetin Alfa Q4W     Total  
Number of Participants  
[units: participants]
 		  108     107     215     430  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     33     26     57     116  
>=65 years     75     81     158     314  
Age  
[units: years]
Mean ± Standard Deviation 		  70.3  ± 13.04     71.7  ± 10.63     71.1  ± 12.48     71  ± 12.18  
Gender  
[units: participants]
 		       
Female     68     73     126     267  
Male     40     34     89     163  



  Outcome Measures
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1.  Primary:   Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment   [ Time Frame: from baseline (Week 1) to the last 12 weeks of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)   [ Time Frame: Weeks 13-37 ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 3

4.  Other Pre-specified:   Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 6

7.  Other Pre-specified:   Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 7

8.  Other Pre-specified:   Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 8

9.  Other Pre-specified:   Number of Participants Who Died   [ Time Frame: 36 weeks of treatment ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Epoetin Alfa QW Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Epoetin Alfa Q2W Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Epoetin Alfa Q4W Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Other Adverse Events
    Epoetin Alfa QW     Epoetin Alfa Q2W     Epoetin Alfa Q4W  
Total, other (not including serious) adverse events        
# participants affected / at risk     59/108     59/107     116/215  
Blood and lymphatic system disorders        
Anaemia * 1      
# participants affected / at risk     6/108 (5.56%)     5/107 (4.67%)     10/215 (4.65%)  
Gastrointestinal disorders        
Diarrhoea * 1      
# participants affected / at risk     8/108 (7.41%)     5/107 (4.67%)     14/215 (6.51%)  
Constipation * 1      
# participants affected / at risk     5/108 (4.63%)     5/107 (4.67%)     15/215 (6.98%)  
Vomiting * 1      
# participants affected / at risk     6/108 (5.56%)     6/107 (5.61%)     10/215 (4.65%)  
Nausea * 1      
# participants affected / at risk     3/108 (2.78%)     6/107 (5.61%)     12/215 (5.58%)  
General disorders        
Oedema * 1      
# participants affected / at risk     5/108 (4.63%)     13/107 (12.15%)     16/215 (7.44%)  
Oedema peripheral * 1      
# participants affected / at risk     6/108 (5.56%)     10/107 (9.35%)     14/215 (6.51%)  
Fatigue * 1      
# participants affected / at risk     6/108 (5.56%)     5/107 (4.67%)     15/215 (6.98%)  
Infections and infestations        
Urinary tract infection * 1      
# participants affected / at risk     12/108 (11.11%)     8/107 (7.48%)     13/215 (6.05%)  
Nasopharyngitis * 1      
# participants affected / at risk     4/108 (3.70%)     6/107 (5.61%)     15/215 (6.98%)  
Upper respiratory tract infection * 1      
# participants affected / at risk     7/108 (6.48%)     6/107 (5.61%)     9/215 (4.19%)  
Metabolism and nutrition disorders        
Hyperkalaemia * 1      
# participants affected / at risk     7/108 (6.48%)     7/107 (6.54%)     18/215 (8.37%)  
Gout * 1      
# participants affected / at risk     6/108 (5.56%)     4/107 (3.74%)     7/215 (3.26%)  
Musculoskeletal and connective tissue disorders        
Pain in extremity * 1      
# participants affected / at risk     6/108 (5.56%)     5/107 (4.67%)     10/215 (4.65%)  
Arthralgia * 1      
# participants affected / at risk     5/108 (4.63%)     4/107 (3.74%)     11/215 (5.12%)  
Back pain * 1      
# participants affected / at risk     7/108 (6.48%)     5/107 (4.67%)     7/215 (3.26%)  
Nervous system disorders        
Dizziness * 1      
# participants affected / at risk     3/108 (2.78%)     7/107 (6.54%)     18/215 (8.37%)  
Headache * 1      
# participants affected / at risk     5/108 (4.63%)     6/107 (5.61%)     14/215 (6.51%)  
Respiratory, thoracic and mediastinal disorders        
Cough * 1      
# participants affected / at risk     2/108 (1.85%)     7/107 (6.54%)     15/215 (6.98%)  
Vascular disorders        
Hypertension * 1      
# participants affected / at risk     11/108 (10.19%)     14/107 (13.08%)     24/215 (11.16%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 11.1



  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Peter Bowers
Organization: J&J PRD
phone: 908-927-2116


No publications provided


Responsible Party: Sr. Medical Director, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00440466     History of Changes
Other Study ID Numbers: CR010414, EPOAKD3002
Study First Received: February 26, 2007
Results First Received: May 13, 2010
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration