NCT00377962

Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.

Conditions

• Disorder Related to Cardiac Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
DRUG	Mycophenolic acid (MPA)/azathioprine (AZA)	In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
DRUG	Calcineurin inhibitors (CNI)	Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
DRUG	Steroids	Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2006-09-19
• Last updated: 2020-07-30
• Results posted: 2011-04-18

Locations

6 sites across 3 countries: Denmark, Norway, Sweden