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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Russian Academy of Medical Sciences
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: December 6, 2012
Last verified: December 2012

July 7, 2010
December 6, 2012
September 2010
September 2013   (final data collection date for primary outcome measure)
  • patient survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Graft survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Not Provided
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 Campath 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
100 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
Not Provided
  • cyclosporine group
    cyclosporine group - after Campath induction cyclosporine will be administered
  • tacrolimus group
    tacrolimus group - after Campath induction tacrolimus will be administered
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • recipient of kidney allograft
  • previous Campath induction

Exclusion Criteria:

  • CNI intolerance
Both
6 Months to 60 Years
No
Russian Federation
 
NCT01346397
RSCS-Campath-06
No
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
December 2012

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