Investigation of the protective effects of keratinocyte growth factor (KGF) in a human lipopolysaccharide induced model of acute lung injury

ISRCTN	ISRCTN98813895
DOI	https://doi.org/10.1186/ISRCTN98813895
Clinical Trials Information System (CTIS)	2008-000441-58
Protocol serial number	MRC ref: G0701690; 08005DM-A
Sponsor	Belfast Health and Social Care Trust (UK)
Funders	Medical Research Council (UK) (ref: G0701690), REVIVE (a charity which supports research in the intensive care unit in the Royal Victoria Hospital, Belfast) (UK), Northern Ireland Chest Heart and Stroke (NICHS) (UK), Added as of 30/12/2008:, Research and Development Office, Northern Ireland Health and Social Services, Central Services Agency (UK)

Submission date: 25/04/2008
Registration date: 12/12/2008
Last edited: 19/05/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20564&q=0%c2%ac08%2fNIR02%2f46%c2%ac

Contact information

Dr Danny McAuley
Scientific

Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Does treatment with a clinically relevant dose of keratinocyte growth factor (KGF) reduce pulmonary and systemic inflammation induced by lipopolysaccharide (LPS) inhalation in humans?
Ethics approval(s)	Health and Social Care (HSC) Research Ethics Committee (REC2), Department of Health, Social Services and Public Safety (DHSSPS), approved on 21/07/2008 (ref: 08/NIR02/46)
Health condition(s) or problem(s) studied	Acute lung injury (ALI)
Intervention	Subjects will be randomised to palifermin 60 µg/kg per day or normal saline placebo intravenously for 3 days prior to LPS inhalation.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Keratinocyte growth factor (KGF)
Primary outcome measure(s)	The ability of KGF to reduce alveolar inflammation, as measured by the difference in bronchoalveolar lavage (BAL) receptor for advanced glycation end products (RAGE) concentration between the KGF and placebo treated groups at 6 hours post LPS inhalation.
Key secondary outcome measure(s)	1. Alveolar inflammatory response at 6 hours post LPS inhalation 2. Plasma inflammatory response (C-reactive protein) at 24 hours post LPS inhalation 3. Alveolar matrix metalloproteinase activity at 6 hours post LPS inhalation 4. Intracellular signalling in the alveolar space at 6 hours post LPS inhalation 5. Indices of alveolar epithelial and endothelial function and injury at 6 hours post LPS inhalation
Completion date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	36
Key inclusion criteria	Healthy subjects, both males and females
Key exclusion criteria	1. Age <18 years 2. Pregnancy, breast-feeding or women of childbearing potential not using adequate contraception 3. Serum amylase above upper limit of normal 4. Consent declined
Date of first enrolment	01/08/2008
Date of final enrolment	01/08/2011

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Intensive Care Unit

Belfast
BT12 6BA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes