NCT01346397

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Graft Rejection
• Chronic Allograft Nephropathy
• Polyomavirus-related Transplant Nephropathy

Interventions

Type	Name	Description
DRUG	cyclosporine or tacrolimus	after alemtuzumab, cyclosporine or tacrolimus was administered

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-05-01
• Completion: 2016-05-01
• First posted: 2011-05-03
• Last updated: 2016-11-29
• Results posted: 2016-11-29

Locations

1 site across 1 country: Russia