ABSTRACTS from 16th International COnference on ... - CRRT Online

<strong>ABSTRACTS</strong> FROM 17 TH INTERNATIONAL CONFERENCE ON CRRT,
SAN DIEGO, FEB 14-17, 2012
40. The SAFE-T Consortium: A
Collaborative Approach for the
Qualification of Novel Kidney
Biomarkers with the Regulatory
Authorities
Joe F Keenan, Patrick Murray, Frank
Dieterle, Ralf Schindler, Stefan Sultana,
Scott Adler
SAFE-T Consortium, European
Collaboration
Background: Drug-induced kidney
injury (DIKI) is not an uncommon
adverse event in drug development. The
greatest issue is the late identification of
Acute Kidney Injury due to the current
standards (i.e. serum creatinine (sCr) and
blood urea nitrogen (BUN)) which are
delayed indicators of injury and may not
be significantly changed until 2/3 of the
kidneys function has already been lost.
Over the last three years there has been
progress with preclinical qualification
processes for kidney biomarkers (PSTC
and ILSI HESI qualification with EMA
and FDA). These landmark
qualifications mean that drug companies
may now use certain novel preclinical
markers for real decision making within
their qualification context. Methods:
The principal objective of this new
project is to collect and generate
sufficient clinical data <strong>from</strong> a number or
candidate kidney biomarkers, that will
provide convincing evidence for the
health authorities to endorse these
biomarkers for the detection and
monitoring of drug induced kidney
injuries in specific clinical situations. 22
kidney biomarker have been selected
and are being analytically validated by a
number of technologies (bead-based,
electrochemiluminescence, LC/MS, and
standard microtitre ELISA) by the
participants of the consortium. A number
of patient clinical studies have been
started in key areas (Cisplatin toxicity,
Contrast induced nephropathy and acute
GN) and these samples will provide the
basis for the exploratory phase of the
project. Results: SAFE-T have gained
regulatory feedback on this project and
are actively recruiting patients and
collecting samples. More than half of the
22 kidney markers have been
analytically validated through a series of
internal bar meetings. Studies have been
designed and initiated to collect samples
for analysis of kidney injury biomarkers
in clinical settings of acute kidney injury
(cisplatin exposure, radiocontrast
exposure and acute glomerulonephritis).
Conclusions: A SAFE-T DIKI status
update including regulatory strategy,
assay validation and study designs will
be provided. Understanding the profiles
of renal injury biomarkers in the context
of various clinical scenarios of kidney
injury will contribute to the development
of acute kidney injury biomarkers.
41. SAPS3 Score as Mortality Rate
Predictors in Patients Treated with
Continuous Renal Replacement
Therapy
Jin Kuk Kim, Eun Jung Kim, Moo Yong
Park, Soo Jeong Choi, Seung Duk
Hwang, You Kyoung Lee
Soonchunhyang University Hospital
Purpose: Acute kidney injury (AKI) is a
frequent condition that requires
continuous renal replacement therapy
(CRRT), which has a high mortality rate
in intensive care unit (ICU) patients. We
evaluated the Simplified Acute
Physiology Score 3 (SAPS 3) and Acute
Physiology and Chronic Health
Evaluation II (APACHE II) score,
determined at the start of CRRT, for
predicting mortality in AKI patients
treated with CRRT. Methods: We
retrospectively analyzed the
demographic, clinical, and laboratory
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