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

NCT01346397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2016-11-29

Study results available
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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.

Conditions

  • Acute Graft Rejection
  • Chronic Allograft Nephropathy
  • Polyomavirus-related Transplant Nephropathy

Interventions

DRUG

cyclosporine or tacrolimus

after alemtuzumab, cyclosporine or tacrolimus was administered

Sponsors & Collaborators

  • Russian Scientific Center of Surgery

    collaborator UNKNOWN

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Michael M Kaabak, professor · Russian Scientific Center of Surgery RAMS

Eligibility

Min Age
6 Months
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-05-31
Completion
2016-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01346397 on ClinicalTrials.gov