Transplant Trial Watch

Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial.

Hornum, M., et al.

Journal of Heart & Lung Transplantation 2020; 39(6): 541-550.


Aims
The aim of this study was to evaluate whether pre-operative and 12-week post-operative treatment with felodipine, a calcium channel blocker, would lead to a reduction in the decline of glomerular filtration rate (GFR).

Interventions
Patients were randomly assigned at a 1:1 ratio to receive felodipine or a matching placebo.

Participants
41 lung transplant recipients.

Outcomes
The primary endpoint was the average change in GFR from baseline to 12 weeks following lung transplant. The secondary endpoints were the average change in GFR from baseline to 52 weeks posttransplant, change in serum creatinine, area under the curve (AUC) B-cyclosporine, primary graft dysfunction, rejection rates, and surgical complications at 12 weeks.

Follow-up
1 year

CET Conclusions
The double-blinded, randomised controlled trial investigated if the calcium channel blocker felodipine started pre-operatively and continued for 12 weeks reduced the decline in glomerular filtration rate (GFR) in adult lung transplant recipients. The sample size calculation was based on the primary outcome change in GFR from baseline to 3 months posttransplant and showed that 42 patients were needed to detect an absolute difference of 50% between the two arms with a power of 80%. Thirty-nine patients were randomised according to a computer-generated sequence to receive felodipine or a matching placebo (identical looking tablet). Treatment adherence of at least 80% was achieved in only 55% of the felodipine and 53% of the placebo groups. The intention to treat analysis showed that the decline in the felopidine group was significantly smaller compared to the placebo group at 3 months (difference 17 ml/min/1.73 m2, 95% confidence interval (CI): 4−29 ml/min/1.73 m2, p=0.01). At 12 months the difference was still 12 ml/min/1.73 m2 (95% CI: 0−24 ml/min/1.73 m2, p=0.05).

Jadad score
5

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrial.gov - NCT02744872

Funding source
Not reported