Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation (NOCTX-2)

Dianet Dialysis Centers

Status and phase: Terminated; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01276834

2009-011605-16 (EudraCT Number)

NOCTX-2

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

everolimus-based immunosuppression

Experimental group

Description:

immunosuppression with everolimus, prednisone and mycophenolate

Treatment:

Drug: everolimus

standard immunosuppression

Active Comparator group

Description:

immunosuppression with tacrolimus, prednisone and mycophenolate

Treatment:

Drug: everolimus