Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

Phase 4

Terminated

• Conditions: Renal Transplantation
• Interventions: Drug: everolimus

• Registration Number: NCT01276834
• Lead Sponsor: Dianet Dialysis Centers

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
everolimus-based immunosuppression	everolimus	immunosuppression with everolimus, prednisone and mycophenolate
standard immunosuppression	everolimus	immunosuppression with tacrolimus, prednisone and mycophenolate

Primary Outcome Measures

Name	Time	Method
change in coronary artery calcification score	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.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands