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

October 4, 2016 updated by: Michael Kaabak, Russian Academy of Medical Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119992
        • National Research Centre of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)

Description

Inclusion Criteria:

  • first kidney allograft recipients
  • alemtuzumab induction

Exclusion Criteria:

  • CNI intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cyclosporine group
cyclosporine group - after alemtuzumab induction cyclosporine was administered
Drug: cyclosporine or tacrolimus
after alemtuzumab, cyclosporine or tacrolimus was administered
tacrolimus group
tacrolimus group - after alemtuzumab induction tacrolimus was administered
Drug: cyclosporine or tacrolimus
after alemtuzumab, cyclosporine or tacrolimus was administered

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Academy of Medical Sciences

Collaborators

Russian Scientific Center of Surgery

Investigators

  • Principal Investigator: Michael M Kaabak, professor, Russian Scientific Center of Surgery RAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCS-Campath-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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