EUCTR2007-002763-27-NL进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
- •11.Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.
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