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Completed

NCT Number: NCT01346397

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

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.

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Key information

Conditions

Acute Graft Rejection Behavior Chronic Allograft Nephropathy Polyomavirus-related Transplant Nephropathy Rejection, Psychology Social Behavior

Age range

6 month–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Research Centre of Surgery

Moscow, 119992, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first kidney allograft recipients
  • alemtuzumab induction

Exclusion criteria

  • CNI intolerance

Treatment and study plan

cyclosporine or tacrolimus

Drug

after alemtuzumab, cyclosporine or tacrolimus was administered

Primary outcomes

  1. Patient Survival

    Time frame: 5 years

    in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%

  2. Graft Survival

    Time frame: 5 years

    in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Collaborators

  • Russian Scientific Center of Surgery

Registry information

Official study title

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

Acronym: RSCS-Campath

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
May 3, 2011
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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