Prospective, randomized, long-term study compairing a Neoral (C-0h monitoring)-based steroid-free to an everolimus-myfortic based, calcineurin-inhibitor-free immunosuppressive treatment on graft function and on the long term impact on cardiovascular risk factors after de novo kidney transplantation. - Première

• Conditions: De novo” renal transplantation

• Registration Number: EUCTR2005-004607-11-BE
• Lead Sponsor: Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-First or second kidney transplantation
-Males and females 18 years old or older
-Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml.
-Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Multiple organ transplantation (eg. Kidney-pancreas, kidney-heart, kidney-liver,…)
-Transplantation of a patient who got another organ transplant previously
-Recipients of HLA-identical living-related renal transplants
-Patients with PRA > 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European (black) patients.
-Recipients of non-heart beating donor
-Pregnant or lactating women
-WBC < 2.5 x 109/L (IU), platelet count < 100 x 109/L (IU), or Hb < 6 g/dl at the time of entry into the study
-Active peptic ulcer
-Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
-Known HIV-1 or HTLV-1 positive tests
-History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
-The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
-Patients receiving bile acid sequestrants
-Psychological illness or condition interfering with the patient’s compliance or ability to understand the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified