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

Completed

• Conditions: Chronic Allograft Nephropathy; Acute Graft Rejection; Polyomavirus-related Transplant Nephropathy
• Interventions: Drug: cyclosporine or tacrolimus

• Registration Number: NCT01346397
• Lead Sponsor: Russian Academy of Medical Sciences

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 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Primary Completion: 2013-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Results First Submitted: 2016-10-04
• Results First Submitted QC: 2016-10-04
• Last Update Submitted: 2016-10-04
• Results First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• first kidney allograft recipients
• alemtuzumab induction

Exclusion Criteria

• CNI intolerance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cyclosporine group	cyclosporine or tacrolimus	cyclosporine group - after alemtuzumab induction cyclosporine was administered
tacrolimus group	cyclosporine or tacrolimus	tacrolimus group - after alemtuzumab induction tacrolimus was administered

Primary Outcome Measures

Name	Time	Method
Patient Survival	5 years	in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Graft Survival	5 years	in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

Trial Locations

Locations (1)

National Research Centre of Surgery; 🇷🇺 Moscow, Russian Federation