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

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ClinicalTrials.gov Identifier: NCT01346397
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):

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

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
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 

  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
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 
[Units: Years]
Mean (Standard Deviation)
 19  (14)   21  (15)   20  (14) 
[Units: Participants]
Female   33   35   68 
Male   52   40   92 
Deceased donor kidney transplant recipients 
[Units: Participants]
 28   21   49 

  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

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

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