Trial | NCT01276834  Report issue

Title

Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    everolimus ...

  • Study Participants

    13
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.
Study Started
Sep 30
2010
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Aug 07
2017

Drug everolimus

comparison of everolimus-based and CNI-based immunosuppression

everolimus-based immunosuppression Experimental

immunosuppression with everolimus, prednisone and mycophenolate

standard immunosuppression Active Comparator

immunosuppression with tacrolimus, prednisone and mycophenolate

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
No Results Posted