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

This study has been completed.
Sponsor:
Collaborator:
Russian Scientific Center of Surgery
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01346397
First received: July 7, 2010
Last updated: October 4, 2016
Last verified: October 2016

July 7, 2010
October 4, 2016
April 2009
May 2013   (final data collection date for primary outcome measure)
  • Patient Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
  • Graft Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
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Complete list of historical versions of study NCT01346397 on ClinicalTrials.gov Archive Site
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Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients

After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.
Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
10 Years
Retention:   Samples With DNA
Description:
blood and urine, taken at the time of protocol or case biopsies will be deeply freeze and stocked for future examination for NAT or other molecules - candidates for diagnostic markers.
Probability Sample
Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)
  • Acute Graft Rejection
  • Chronic Allograft Nephropathy
  • Polyomavirus-related Transplant Nephropathy
Drug: cyclosporine or tacrolimus
after alemtuzumab, cyclosporine or tacrolimus was administered
  • cyclosporine group
    cyclosporine group - after alemtuzumab induction cyclosporine was administered
    Intervention: Drug: cyclosporine or tacrolimus
  • tacrolimus group
    tacrolimus group - after alemtuzumab induction tacrolimus was administered
    Intervention: Drug: cyclosporine or tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
May 2016
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • first kidney allograft recipients
  • alemtuzumab induction

Exclusion Criteria:

  • CNI intolerance
Both
6 Months to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01346397
RSCS-Campath-06
No
Not Provided
Not Provided
Michael Kaabak, Russian Academy of Medical Sciences
Russian Academy of Medical Sciences
Russian Scientific Center of Surgery
Principal Investigator: Michael M Kaabak, professor Russian Scientific Center of Surgery RAMS
Russian Academy of Medical Sciences
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP