Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation (NOCTX-2)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2011 by Dianet Dialysis Centers
Sponsor:
Dianet Dialysis Centers
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 | 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 Cardiovascular Diseases Vascular Diseases Everolimus |
Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015