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 MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•Age: at least 18 years
•Acceptable renal function (eGFR Nankivell > 30 ml/min, proteinuria < 1.0 g/day)
•3 - 4 months post renal transplantation with non-heart-beating donor graft

•Banff grade > 2 acute or vascular rejection at any time during this transplant pre-randomization
•Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant)..
•Evidence of active systemic or localized major infection.
•Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor.
•Immunosuppressive therapies other than those described above
•Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or ANC < 1000, platelet count < 100,000/mm3.
•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.
•Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.

发起方