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

This study is currently recruiting participants.
Verified December 2012 by Russian Academy of Medical Sciences
Sponsor:
Collaborator:
Russian Scientific Center of Surgery
Information provided by (Responsible Party):
Michael Kaabak, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01346397
First received: July 7, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

After Campath 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
Acute Graft Rejection
Chronic Allograft Nephropathy
Polyomavirus-related Transplant Nephropathy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 100 Years
Official Title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • patient survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Graft survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
cyclosporine group
cyclosporine group - after Campath induction cyclosporine will be administered
tacrolimus group
tacrolimus group - after Campath induction tacrolimus will be 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

Ages Eligible for Study:   6 Months to 60 Years
Genders Eligible for Study:   Both
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:

  • recipient of kidney allograft
  • previous Campath induction

Exclusion Criteria:

  • CNI intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346397

Locations
Russian Federation
National Research Centre of Surgery Recruiting
Moscow, Russian Federation, 119992
Contact: Michael M. Kaabak, MD, PhD     +74992481344     kaabak@hotmail.com    
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

No publications provided

Responsible Party: Michael Kaabak, professor, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01346397     History of Changes
Other Study ID Numbers: RSCS-Campath-06
Study First Received: July 7, 2010
Last Updated: December 6, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Russian Academy of Medical Sciences:
rejection
survival
campath
cyclosporine
tacrolimus

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Tacrolimus
Campath 1G
Alemtuzumab
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013