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

This study has been terminated.
(insufficient patients enrolled)
UMC Utrecht
Information provided by (Responsible Party):
dr. M.P. Kooistra, Dianet Dialysis Centers Identifier:
First received: January 12, 2011
Last updated: August 11, 2015
Last verified: August 2015
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
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:

Further study details as provided by Dianet Dialysis Centers:

Primary Outcome Measures:
  • 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.

Enrollment: 13
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01276834

University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Dianet Dialysis Centers
UMC Utrecht
Principal Investigator: Franka E van Reekum, MD UMC Utrecht
  More Information

Responsible Party: dr. M.P. Kooistra, MD, PhD, Dianet Dialysis Centers Identifier: NCT01276834     History of Changes
Other Study ID Numbers: NOCTX-2
2009-011605-16 ( EudraCT Number )
Study First Received: January 12, 2011
Last Updated: August 11, 2015

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 28, 2017