Clinical Trial: Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients

Brief Summary:

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.

Detailed Summary: 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.
Sponsor: Russian Academy of Medical Sciences

Current Primary Outcome:

• Patient Survival [ Time Frame: 5 years ]
  in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
• Graft Survival [ Time Frame: 5 years ]
  in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Russian Academy of Medical Sciences

Dates:
Date Received: July 7, 2010
Date Started: April 2009
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016