Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
Overview
- Phase
- Phase 4
- Intervention
- everolimus
- Conditions
- Renal Transplantation
- Sponsor
- Dianet Dialysis Centers
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- change in coronary artery calcification score
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
B.C. van Jaarsveld, MD PhD
MD, PhD
Dianet Dialysis Centers
Eligibility 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
Arms & Interventions
everolimus-based immunosuppression
immunosuppression with everolimus, prednisone and mycophenolate
Intervention: everolimus
standard immunosuppression
immunosuppression with tacrolimus, prednisone and mycophenolate
Intervention: everolimus
Outcomes
Primary Outcomes
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.