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

NCT ID: NCT01346397

Last Updated: 2016-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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Acute Graft Rejection Chronic Allograft Nephropathy Polyomavirus-related Transplant Nephropathy

Keywords

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rejection survival alemtuzumab cyclosporine tacrolimus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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cyclosporine group

cyclosporine group - after alemtuzumab induction cyclosporine was administered

cyclosporine or tacrolimus

Intervention Type DRUG

after alemtuzumab, cyclosporine or tacrolimus was administered

tacrolimus group

tacrolimus group - after alemtuzumab induction tacrolimus was administered

cyclosporine or tacrolimus

Intervention Type DRUG

after alemtuzumab, cyclosporine or tacrolimus was administered

Interventions

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cyclosporine or tacrolimus

after alemtuzumab, cyclosporine or tacrolimus was administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* first kidney allograft recipients
* alemtuzumab induction

Exclusion Criteria

* CNI intolerance
Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Russian Scientific Center of Surgery

UNKNOWN

Sponsor Role collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Michael Kaabak

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael M Kaabak, professor

Role: PRINCIPAL_INVESTIGATOR

Russian Scientific Center of Surgery RAMS

Locations

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National Research Centre of Surgery

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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RSCS-Campath-06

Identifier Type: -

Identifier Source: org_study_id