ordic Certican trial in heart and lung transplantation (NOCTET)

• Conditions: Heart transplantation or lung transplantation

• Registration Number: EUCTR2005-002060-28-SE
• Lead Sponsor: ovartis Nordic Countries, Business Unit Transplantation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified