Randomised comparison of two different immunosuppressive regimens on progression of arteriosclerosis in renal transplant patients. Extension of NOCTX-study: Is progression of arteriosclerosis in ESRD patients inhibited by nocturnal hemodialysis or renal transplantation?

Randomised comparison of two different immunosuppressive regimens on progression of arteriosclerosis in renal transplant patients. Extension of NOCTX-study: Is progression of arteriosclerosis in ESRD patients inhibited by nocturnal hemodialysis or renal transplantation? - Coronary artery calcifications in renal transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37133

Enrollment

Registered

2010-07-21

Start date

2010-11-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

cardiovascular disease in renal transplant patients

Interventions

Patients with ESRD, 18-75 yr, who undergo a living or postmortal transplant are randomised at 3 months after transplantation to: A: continuation with CNI-based immunosuppression B: switch to mTOR-bas

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age between 18-75 yr - willingness to provide written informed consent - ability to understand the study procedures

Exclusion criteria

Exclusion criteria: - life expectancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is: - change in coronary artery calcification score	—

Secondary

Measure	Time frame
The secondary endpoints of the study are: - change in pulse wave velocity - change in coronary artery stenosis - association between calcium, phosphate, PTH and change in coronary artery calcification score - association between high-sensivitity-CRP, interleukin-6, interleukin-1, vonWillebrandfactor, myeloperoxidase, and change in coronary artery calcification score - association between fetuin A, osteoprotegerin and matrix-Gla protein and change in coronary artery calcification score - cardiovascular events and mortality - renal function	—

Measure

Time frame

The secondary endpoints of the study are: - change in pulse wave velocity - change in coronary artery stenosis - association between calcium, phosphate, PTH and change in coronary artery calcification score - association between high-sensivitity-CRP, interleukin-6, interleukin-1, vonWillebrandfactor, myeloperoxidase, and change in coronary artery calcification score - association between fetuin A, osteoprotegerin and matrix-Gla protein and change in coronary artery calcification score - cardiovascular events and mortality - renal function

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)