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Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation (RSCS-Campath)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346397
First Posted: May 3, 2011
Last Update Posted: November 29, 2016
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.
Collaborator:
Russian Scientific Center of Surgery
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
Results First Submitted: October 4, 2016  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Acute Graft Rejection
Chronic Allograft Nephropathy
Polyomavirus-related Transplant Nephropathy
Intervention: Drug: cyclosporine or tacrolimus

  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
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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
Cyclosporine Group cyclosporine group - after Campath induction cyclosporine will be administered
Tacrolimus Group tacrolimus group - after Campath induction tacrolimus will be administered

Participant Flow:   Overall Study
    Cyclosporine Group   Tacrolimus Group
STARTED   85   85 
COMPLETED   85   85 
NOT COMPLETED   0   0 



  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
Cyclosporine Group cyclosporine group - after alemtuzumab induction cyclosporine was administered
Tacrolimus Group

tacrolimus group - after alemtuzumab induction tacrolimus was administered

cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered

Total Total of all reporting groups

Baseline Measures
   Cyclosporine Group   Tacrolimus Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   85   170 
Age 
[Units: Years]
Mean (Standard Deviation)
 19  (14)   21  (15)   20  (14) 
Gender 
[Units: Participants]
     
Female   33   35   68 
Male   52   40   92 
Deceased donor kidney transplant recipients 
[Units: Participants]
 28   21   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Survival   [ Time Frame: 5 years ]

2.  Primary:   Graft Survival   [ Time Frame: 5 years ]


  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: Dr Michael Kaabak
Organization: Boris Petrovsky research cener od surgery
phone: +74992481344
e-mail: kaabak@hotmail.com



Responsible Party: Michael Kaabak, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01346397     History of Changes
Other Study ID Numbers: RSCS-Campath-06
First Submitted: July 7, 2010
First Posted: May 3, 2011
Results First Submitted: October 4, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016