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Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation (NOCTX-2)
This study has been terminated.
(insufficient patients enrolled)
Sponsor:
Dianet Dialysis Centers
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
dr. M.P. Kooistra, Dianet Dialysis Centers
ClinicalTrials.gov Identifier:
NCT01276834
First received: January 12, 2011
Last updated: August 11, 2015
Last verified: August 2015
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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 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 dr. M.P. Kooistra, 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
|
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01276834
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | dr. M.P. Kooistra, MD, PhD, Dianet Dialysis Centers |
| ClinicalTrials.gov 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:
|
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 |
ClinicalTrials.gov processed this record on June 27, 2017