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Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation (NOCTX-2)

This study is currently recruiting participants.
Verified January 2011 by Dianet Dialysis Centers
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
Dianet Dialysis Centers
ClinicalTrials.gov Identifier:
NCT01276834
First received: January 12, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.


Condition Intervention Phase
Renal Transplantation
 Drug: everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dianet Dialysis Centers:

Primary Outcome Measures:
  • change in coronary artery calcification score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients.

    The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.



Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus-based immunosuppression
immunosuppression with everolimus, prednisone and mycophenolate
 Drug: everolimus
comparison of everolimus-based and CNI-based immunosuppression
Active Comparator: standard immunosuppression
immunosuppression with tacrolimus, prednisone and mycophenolate
 Drug: everolimus
comparison of everolimus-based and CNI-based immunosuppression

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-75 yr
  • Willingness to provide written informed consent
  • Ability to understand the study procedures

Exclusion Criteria:

  • Life expectancy < 3 months
  • Claustrophobia
  • Allergy to iodinated contrast
  • Treatment incompliance
  • Pregnancy
  • Highly HLA-sensitized patients
  • Severe dyslipidemia or proteinuria
  • Severe leucopenia or thrombocytopenia
  • GFR < 30 ml/min
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276834

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Franka E van Reekum, MD     +31 88 7555555     f.vanreekum@umcutrecht.nl    
Principal Investigator: Franka E van Reekum, MD            
Sponsors and Collaborators
Dianet Dialysis Centers
UMC Utrecht
  More Information

No publications provided

Responsible Party: Franka van Reekum, University Medical Center Utrecht The Netherlands
ClinicalTrials.gov Identifier: NCT01276834     History of Changes
Other Study ID Numbers: NOCTX-2, 2009-011605-16
Study First Received: January 12, 2011
Last Updated: January 12, 2011
Health Authority: The Netherlands:METC University Medical Center Utrecht

Additional relevant MeSH terms:
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013