At a glance
ClinicalIndex Comparison Record- ✓Heart or lung transplant recipients >12 months post-transplant
- ✓Currently receiving calcineurin inhibitors (cyclosporine or tacrolimus)
- ✓Glomerular filtration rate (GFR) 20–70 mL/min/1.73m², with documented renal decline if GFR 60–70
- ✓Capable of providing written informed consent and participating for 12 months
- ✕Multiple organ transplant recipients
- ✕GFR <20 or >70 mL/min/1.73m²
- ✕Acute rejection episode treated within the last 3 months
- ✕Severe thrombocytopenia (<50,000/mm³), leukopenia (≤2,500/mm³), or anemia (<8 g/dL hemoglobin)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months
In Brief
A Phase 4 clinical trial evaluating Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), and 2 other interventions for Disorder Related to Cardiac Transplantation. Completed, enrolled 282 participants across 6 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
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.