NCT02744872

Copenhagen Acute Renal Complications After Transplantations Study Group

Prospektivt Randomiseret Dobbeltblindt Placebo-kontrolleret Studie af, Calciumkanalblokade påbegyndt Inden Operation: Med Henblik på at Forebygge Ciclosporin Induceret Nefropati Efter Lungetransplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output. The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy. The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo. Study population is all patients listed for lung transplantation in Denmark in the study period. Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks Primary endpoint is change in renal function as measured by glomerular filtration rate using chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated group compared with the placebo group.

Detailed description

Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes. Calcium channel blockers exert renal effects consisting mainly of renal vasodilation and facilitation of renal excretion of sodium through a direct action on renal tubules. Calcium channel blockers improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output. Studies in both animal models and humans have demonstrated that calcium channel blockers maintain or reduce renal vascular resistance and preserve or enhance renal blood flow and glomerular filtration rate (GFR). The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy. The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo. Study population is all patients listed for lung transplantation in Denmark in the study period. Sample size calculation estimated that 32 patients are needed, 16 patients in each group, with an estimated dropout incidence of 5 patients in each group. This will be able to detect an estimated 50% reduction in the decrease in measured GFR from 40 ml/min in the placebo group to 20 ml/min in treatment group, 80% power and a two-sided t-test, 5 % significance level. Intervention is tablet Felodipine titrated to 10 mg, one daily dose in 12 weeks Renal function is determined by 51-Cr-EDTA clearance measurement at times 0 before transplantation and after 1, 3 and 12 weeks. Primary endpoint is change in renal function as measured by 51-Cr-EDTA clearance in the felodipine treated group compared with the placebo group. Safety is monitored and adverse events are usually mild headache, tachycardia, leg edema, angina pectoris and hypotension.

Conditions

• Disorder Related to Lung Transplantation

Interventions

Type	Name	Description
DRUG	Felodipine	Felodipine 10 mg once daily or identical placebo
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2016-04-20
• Last updated: 2016-10-06

Locations

1 site across 1 country: Denmark