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

Russian Academy of Medical Sciences (RAMS)

Status: Completed

Conditions: Chronic Allograft Nephropathy; Acute Graft Rejection; Polyomavirus-related Transplant Nephropathy

Treatments: Drug: cyclosporine or tacrolimus

Study type: Observational

Funder types: Other

Identifiers

NCT01346397

RSCS-Campath-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 6 months to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• first kidney allograft recipients
• alemtuzumab induction

Exclusion criteria

• CNI intolerance

Trial design

170 participants in 2 patient groups

cyclosporine group

Description:

cyclosporine group - after alemtuzumab induction cyclosporine was administered

Treatment:

Drug: cyclosporine or tacrolimus

tacrolimus group

Description:

tacrolimus group - after alemtuzumab induction tacrolimus was administered

Treatment:

Drug: cyclosporine or tacrolimus