ordic Certican trial in heart and lung transplantation (NOCTET) - NOCTET

ovartis Nordic Countries, Business Unit Transplantation0 个研究点目标入组 282 人开始时间: 2005年7月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male or female patient at least 18 years of age.
•Patient who have undergone a heart or lung transplantation more than 12 months ago.
•Patient receiving Neoral® or Prograf®.
•Patients with a measured or calculated GFR > 20 and <70 mL/min /1,73m2, and in the opinion of the investigator have a deteriorating renal function.
•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

•Patient who is recipient of multiple organ transplants.
•Patient with measured or calculated GFR < 20 mL/min/1,73m2 or > 70 mL/min/1,73m2.
•Patient with a treated acute rejection episode within the last 3 months.
•Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of
•= 2,500/mm3 or with a hemoglobin value < 8 g/dL.
•Presence of severe hypercholesterolemia (= 8,0 mmol/L) or hypertriglyceridemia
•(= 6,0 mmol/L) despite conventional lipid lowering treatment.
•Patient being currently treated or who has been treated with a mTOR inhibitor.
•Patient who had received an investigational drug within 4 weeks.
•Patient who is human immunodeficiency virus positive or who has a current severe systemic infection according to the investigator judgment requiring continued therapy.
•Present use of any other immunosuppressive drugs than Neoral®/Prograf® , MPA/AZA and steroids.
•Patients with a known hypersensitivity to drugs similar to everolimus.

发起方

ovartis Nordic Countries, Business Unit Transplantation