We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346397
First Posted: May 3, 2011
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Russian Scientific Center of Surgery
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
  Purpose

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 Michael Kaabak, 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
Criteria

Inclusion Criteria:

  • first kidney allograft recipients
  • alemtuzumab induction

Exclusion Criteria:

  • CNI intolerance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346397


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

Responsible Party: Michael Kaabak, professor, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01346397     History of Changes
Other Study ID Numbers: RSCS-Campath-06
First Submitted: July 7, 2010
First Posted: May 3, 2011
Results First Submitted: October 4, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Michael Kaabak, Russian Academy of Medical Sciences:
rejection
survival
alemtuzumab
cyclosporine
tacrolimus

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Tacrolimus
Cyclosporins
Cyclosporine
Alemtuzumab
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