Copenhagen Acute Renal Complications After Transplantations Study Group
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 09/30/2016 |
| Enviado pela primeira vez: | 03/29/2016 |
| Inscrição estimada enviada: | 04/18/2016 |
| Postado pela primeira vez: | 04/19/2016 |
| Última atualização enviada: | 10/04/2016 |
| Última atualização postada: | 10/05/2016 |
| Data real de início do estudo: | 08/31/2013 |
| Data Estimada de Conclusão Primária: | 06/30/2016 |
| Data Estimada de Conclusão do Estudo: | 09/30/2016 |
Condição ou doença
Intervenção / tratamento
Drug: Felodipine
Drug: Placebo
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Active Comparator: Felodipine Tablet Felodipin 10 mg x 1 daily | Drug: Felodipine Felodipine 10 mg once daily or identical placebo |
| Placebo Comparator: Placebo Identical placebo once daily | Drug: Placebo Placebo |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - All patients who are undergoing lung transplantation in Denmark Exclusion Criteria: - Fertile women not using contraceptives - Patients allergic to calcium antagonists - Patients receiving treatment with Calcium antagonist 14 days prior to transplant |
Resultado
Medidas de Resultado Primário
1. Change in glomerular filtration rate [week 1, 2, 3 and 12]
