Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation (RSCS-Campath)
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.
Acute Graft Rejection
Chronic Allograft Nephropathy
Polyomavirus-related Transplant Nephropathy
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||100 Years|
|Official Title:||Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients|
- patient survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Graft survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
cyclosporine group - after Campath induction cyclosporine will be administered
tacrolimus group - after Campath induction tacrolimus will be administered
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346397
|National Research Centre of Surgery||Recruiting|
|Moscow, Russian Federation, 119992|
|Contact: Michael M. Kaabak, MD, PhD +74992481344 firstname.lastname@example.org|
|Principal Investigator:||Michael M Kaabak, professor||Russian Scientific Center of Surgery RAMS|