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

ovartis Nordic Countries, Business Unit Transplantation0 sites282 target enrollmentJuly 7, 2005

Overview

No summary available.

Registry

who.int

Start Date

July 7, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Nordic Countries, Business Unit Transplantation

•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.