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Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214201
First received: September 13, 2005
Last updated: September 21, 2012
Last verified: September 2012
Results First Received: August 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Renal Transplant
Intervention: Drug: Calcineurin inhibitor withdrawal

  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
CNI Control Post Campath 1H Standard of Care CNI immunosuppression
CNI Withdrawal Post Campath 1H

Calcineurin inhibitor withdrawal

Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy


Participant Flow:   Overall Study
    CNI Control Post Campath 1H     CNI Withdrawal Post Campath 1H  
STARTED     20     20  
COMPLETED     18     18  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 0  
Death                 0                 2  



  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.
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Reporting Groups
  Description
CNI Control Post Campath 1H Standard of Care CNI immunosuppression
CNI Withdrawal Post Campath 1H

Calcineurin inhibitor withdrawal

Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

Total Total of all reporting groups

Baseline Measures
    CNI Control Post Campath 1H     CNI Withdrawal Post Campath 1H     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     17     33  
>=65 years     4     3     7  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 9.2     55.3  ± 9.4     54.7  ± 9.2  
Gender  
[units: participants]
     
Female     3     5     8  
Male     17     15     32  



  Outcome Measures
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1.  Primary:   Number of Participants With Biopsy Proven Rejection   [ Time Frame: 3 years ]

2.  Secondary:   Serum Creatinine at 36 Months (End of Study)   [ Time Frame: 36 months +/- 60 days ]

3.  Other Pre-specified:   WBC   [ Time Frame: 36 months +/- 60 days ]


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


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: UW Madison
phone: 608-263-2565


No publications provided


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214201     History of Changes
Other Study ID Numbers: 2003-125
Study First Received: September 13, 2005
Results First Received: August 13, 2012
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration