A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts. - PRINS study

Erasmus MC0 sitesAugust 9, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 9, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Age \= 18 years.
•2\.Acceptable renal function (eGFR Nankivell \> 30ml, Proteinuria \< 1\.0 g/day)
•3\.3\-4 months post renal transplantation with a NHBD graft
•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

•1\.Banff grade \> 2 acute or vascular rejection at any time during this transplant pre\-randomization
•2\.Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant)..
•3\.Evidence of active systemic or localized major infection.
•4\.Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
•5\.Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor.
•6\.Immunosuppressive therapies other than those described above
•7\.Planned treatment with voriconazole, cisapride, or ketoconazole, that will not be discontinued prior to randomization.
•8\.Treatment with aminoglycosides, amphotericin B, cisplatin, or other drugs associated with renal dysfunction that is not discontinued prior to enrolment.
•9\.Subjects with a screening/baseline total white blood cell count \< 2,000/mm3 or ANC \< 1000, platelet count \< 100,000/mm3\.
•10\. Fasting triglycerides \> 400 mg/dL (\> 4\.5 mmol/L) or fasting total cholesterol \> 300 mg/dL (\> 7\.8 mmol/L) despite optimal lipid\-lowering therapy.