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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Transplantation | Drug: everolimus | Phase 4 |
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 |

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 |
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
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

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
Netherlands | |
University Medical Center Utrecht | |
Utrecht, Netherlands, 3584 CX |
Principal Investigator: | Franka E van Reekum, MD | UMC Utrecht |
Responsible Party: | B.C. van Jaarsveld, MD PhD, MD, PhD, Dianet Dialysis Centers |
ClinicalTrials.gov Identifier: | NCT01276834 |
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 |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Everolimus |
Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |