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

This study has been completed.
Russian Scientific Center of Surgery
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences Identifier:
First received: July 7, 2010
Last updated: October 4, 2016
Last verified: October 2016

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.

Condition Intervention
Acute Graft Rejection
Chronic Allograft Nephropathy
Polyomavirus-related Transplant Nephropathy
Drug: cyclosporine or tacrolimus

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • Patient Survival [ Time Frame: 5 years ]
    in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%

  • Graft Survival [ Time Frame: 5 years ]
    in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

Biospecimen Retention:   Samples With DNA
blood and urine, taken at the time of protocol or case biopsies will be deeply freeze and stocked for future examination for NAT or other molecules - candidates for diagnostic markers.

Enrollment: 170
Study Start Date: April 2009
Study Completion Date: May 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   6 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)

Inclusion Criteria:

  • first kidney allograft recipients
  • alemtuzumab induction

Exclusion Criteria:

  • CNI intolerance
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Please refer to this study by its identifier: NCT01346397

Russian Federation
National Research Centre of Surgery
Moscow, Russian Federation, 119992
Sponsors and Collaborators
Russian Academy of Medical Sciences
Russian Scientific Center of Surgery
Principal Investigator: Michael M Kaabak, professor Russian Scientific Center of Surgery RAMS
  More Information

Responsible Party: Michael Kaabak, professor, Russian Academy of Medical Sciences Identifier: NCT01346397     History of Changes
Other Study ID Numbers: RSCS-Campath-06
Study First Received: July 7, 2010
Results First Received: October 4, 2016
Last Updated: October 4, 2016

Keywords provided by Russian Academy of Medical Sciences:

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents processed this record on April 26, 2017