Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial.
Boissonnat P, Gaillard S, et al.Trials 2012; 13(1):231
Aims
To evaluate the efficacy of early low dose cyclosporine (CsA) plus mycophenolate mofetil (MMF) on the change in serum creatinine levels in de novo heart transplant recipients.
Interventions
Low dose CsA versus standard dose CsA starting within four days post-surgery. All patients received MMF and corticosteroids.
Participants
95 de novo heart transplant recipients
Outcomes
The primary outcome was renal function assessed by change in serum creatinine levels. Secondary outcomes included creatinine clearance, microalbuminuria, and proteinuria. Immunosuppressive efficacy endpoints included the incidence of acute rejection episodes, cardiac function (ejection and shortening fractions), and treatment failure (defined as death or withdrawal from the study for any reason).
Follow-up
12 months
CET Conclusions
In this small but well designed trial a lower dose of cyclosporine for 3 months after cardiac transplantation did not result in a significant improvement in renal function at one year, which was the primary outcome to be assessed.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov - NCT00159159