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

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ClinicalTrials.gov Identifier: NCT01276834
Recruitment Status : Terminated (insufficient patients enrolled)
First Posted : January 13, 2011
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
B.C. van Jaarsveld, MD PhD, Dianet Dialysis Centers

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Renal Transplantation Drug: everolimus Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. change in coronary artery calcification score [ Time Frame: 3 years ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01276834


Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Dianet Dialysis Centers
UMC Utrecht
Investigators
Principal Investigator: Franka E van Reekum, MD UMC Utrecht
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: B.C. van Jaarsveld, MD PhD, MD, PhD, Dianet Dialysis Centers
ClinicalTrials.gov Identifier: NCT01276834     History of Changes
Other Study ID Numbers: NOCTX-2
2009-011605-16 ( EudraCT Number )
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

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