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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01276834

Acronym

NOCTX-2

Enrollment

Registered

2011-01-13

Start date

2010-09-30

Completion date

2012-07-31

Last updated

2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

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.

Interventions

DRUGeverolimus

comparison of everolimus-based and CNI-based immunosuppression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026