Respiratory Trials·org

Lung transplantation · Immunosuppression after lung transplant

ScanCLAD randomised trial

Once-per-day tacrolimus versus twice-per-day ciclosporin after lung transplantation

ScanCLAD trial design and results
Design Multicentre randomised controlled trial in Scandinavia
Treatment Once-daily tacrolimus-based immunosuppression
Control Twice-daily ciclosporin-based immunosuppression
Population 249 patients who underwent double lung transplantation and received at least one dose of study drug
Follow-up 3 years
Primary endpoint Incidence of chronic lung allograft dysfunction at 3 years
Result Immunosuppression based on once-daily tacrolimus significantly reduced the incidence of chronic lung allograft dysfunction compared with twice-daily ciclosporin. Infection was the commonest adverse event in both arms and was numerically more frequent with tacrolimus, 568 events versus 453 with ciclosporin; acute rejection ran the other way, 98 versus 165 events.
Secondary endpoints Acute rejection, survival, renal function, infection

Immunosuppression based on use of tacrolimus once per day significantly reduced the incidence of CLAD compared with use of ciclosporin twice per day. These findings support the use of tacrolimus-based immunosuppression after lung transplantation.

The trial authors, in the published abstract

How it has aged

Settles a choice that had been made on habit and centre preference for decades, using the outcome that actually limits survival after lung transplantation. Chronic allograft dysfunction, not acute rejection, is what kills these patients.

Publications

Effect of once-per-day tacrolimus versus twice-per-day ciclosporin on 3-year incidence of chronic lung allograft dysfunction after lung transplantation in Scandinavia (ScanCLAD): a multicentre randomised controlled trial

Dellgren G, Lund TK, Raivio P, et al. Effect of once-per-day tacrolimus versus twice-per-day ciclosporin on 3-year incidence of chronic lung allograft dysfunction after lung transplantation in Scandinavia (ScanCLAD): a multicentre randomised controlled trial. Lancet Respir Med 2024 Jan;12(1):34-44.

  • Lower 3-year incidence of chronic lung allograft dysfunction
  • Once-daily dosing may also aid adherence