Improvement in Renal Function after Everolimus Introduction and Calcineurin Inhibitor Reduction in Maintenance Thoracic Transplant Recipients: The Significance of Baseline Glomerular Fltration Rate.
Arora S, Gude E, et al.Journal of Heart & Lung Transplantation, 31(3): 259-265, 2012.
Aims
To assess whether everolimus introduction combined with calcineurin inhibitor (CNI) reduction would improve renal function in thoracic transplant recipients with advanced renal failure.
Interventions
Everolimus combined with low-dose CNI versus standard CNI therapy.
Participants
190 heart and 92 lung transplant recipients with advanced renal failure who were at least 1 year posttransplant.
Outcomes
Primary endpoint was the mean change in measured glomerular filtration rate (mGFR). Covariates for analysis of covariance included baseline mGFR value, time since transplantation, type of transplantation (heart or lung), adjunctive immunosuppressive therapy (azathioprine or mycophenolate mofetil) and recipient age.
Follow-up
12 months
CET Conclusions
The introduction of everolimus with reduction of CNI significantly improved renal function in thoracic transplant patients with pre-existing advanced renal failure, but this effect was only seen with conversion in the first 5 years after transplantation. However there were more serious adverse events reported in the everolimus conversion patients.
Data analysis
Per protocol analysis
Quality notes
This is a sub-analysis of a previous publication of the same RCT: Gullestad L, Iversen M, Mortensen SA, et al. Everolimus with reduced calcineurin inhibitor in thoracic transplant recipients with renal dysfunction: a multicenter, randomized trial. Transplantation 2010;89:864-72. The methodological quality assessment was based on the previous publication.
Trial registration
NCT00377962 (ClinicalTrials.gov)