CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 170 enrolled
Drug / intervention
cyclosporine or tacrolimusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01346397
NCT01346397N/ACompleted

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

Russian Academy of Medical Sciences·observational·Posted May 3, 2011·Updated Nov 29, 2016

In Brief

An observational study evaluating cyclosporine or tacrolimus for Acute Graft Rejection and 2 related conditions. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesRussia

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2011
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2013
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.2 years ago

Interventions

cyclosporine or tacrolimusdrug

after alemtuzumab, cyclosporine or tacrolimus was administered