A Randomized Open-label Study: Efficacy and safety of basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids in Pancreatic Allograft Recipients - The Norwegian pancreas-Tx study

Oslo University Hospital Rikshospitalet0 个研究点开始时间: 2012年12月12日最近更新: 2013年4月22日

试验速览

暂无简介。

•- Age =18 years
•- Patients who receive a primary or secondary pancreas transplant, with or without a
•simultaneous kidney transplant (SPK).
•- Women who are of childbearing potential must have a negative serum pregnancy test at
•- Operability has to be ascertained by preop. examination, performed by nephrologist,
•transplant surgeon and anaesthesiologist.
•- Signed and dated 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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Evidence of systemic infection.
•- Presence of unstable cardiovascular disease.
•- Malignancy < 5 years prior to entry into the trial (with the exception of adequately treated
•basal cell or squamous cell carcinomas of the skin).
•- Panel-reactive antibodies (PRA) > 20% or the presence of donor-specific antigens (DSA).
•- Use of investigational agents <1 month prior to entry into the trial.
•- Any positive test for HBV, HBC or HIV.

发起方

Oslo University Hospital Rikshospitalet