Trial Acronym KARE
Clinical Area Critical Care
Description Keratinocyte growth factor in Acute lung injury to REduce pulmonary dysfunction – a randomised placebo controlled trial (KARE).
Status Closed
Date Opened to Recruitment February 2011
Target Recruitment 60
Recruitment to date 60
Date Opened to Recruitment 31 December 2013
Trial Design Prospective, randomised, double-blind, placebo-controlled phase 2 , clinical study of palifermin in patients with ALI.
Study Aim The hypothesis is that treatment with palifermin will improve surrogate clinical outcomes in adult patients with ALI and is safe.The objectives of the trials are:
1) To conduct a randomised, double-blind, placebo-controlled phase 2 trial of palifermin for the treatment of ALI
2) To study the biological mechanisms of palifermin on pulmonary and systemic neutrophil function and inflammation; alveolar epithelial and endothelial function protease:antiprotease balance and lung extracellular matrix degradation and turnover
Chief Investigator Professor Danny McAuley
Sponsor Belfast Health and Social Care Trust
Funder Public Health Agency, Health and Social Care, Research and Development