The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has proposed the continuation and expansion of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will evolve into a network of up to 8 Clinical Centers (CCs), the Data Coordinating Center (DCC), and the NIDDK Project Office. The purpose of this research program is to enhance the enrollment of cases and controls from a wide demographic and geographic distribution, devise testable hypotheses to assess the role of genetic variability in DILI, perform pharmacogenetic analysis and develop the infrastructure needed to find phenotypic-genotypic associations, disseminate the information to the greater scientific community, and develop, in conjunction with the National Library of Medicine, an authoritative and complete internet website for drug-induced liver injury. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for DILIN. In this role, we will apply our extensive experience and research infrastructure to coordinate, support and facilitate the activities of the network. In particular, we will attend to the following specific aims: (1) nurture the efficient organizational structure developed in the initial grant period;(2) invoke quality assurance procedures to ensure fidelity in conducting these studies;(3) integrate the new clinical centers into DILIN;(4) maintain data management systems developed in the initial grant period to safeguard the completeness, accuracy and timeliness of the accumulating data;(5) continue reports developed in the initial grant period to chart progress in conducting these studies;(6) contribute in a substantive manner to design and conduct of pharmacogenetic studies;(7) contribute to the NLM initiative to developed an authoritative DILI website;(8) contribute to the development of a validated, diagnostic instrument for DILI;(9) provide appropriate and capable leadership and expertise in biostatistics and study design;and (10) support ancillary studies and prospective studies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK065176-09
Application #
8132966
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (O1))
Program Officer
Serrano, Jose
Project Start
2003-09-30
Project End
2013-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
9
Fiscal Year
2011
Total Cost
$1,086,325
Indirect Cost
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Ahmad, Jawad; Odin, Joseph A; Hayashi, Paul H et al. (2017) Identification and Characterization of Fenofibrate-Induced Liver Injury. Dig Dis Sci 62:3596-3604
de Boer, Ynto S; Kosinski, Andrzej S; Urban, Thomas J et al. (2017) Features of Autoimmune Hepatitis in Patients With Drug-induced Liver Injury. Clin Gastroenterol Hepatol 15:103-112.e2
Chalasani, Naga; Reddy, K Rajender K; Fontana, Robert J et al. (2017) Idiosyncratic Drug Induced Liver Injury in African-Americans Is Associated With Greater Morbidity and Mortality Compared to Caucasians. Am J Gastroenterol 112:1382-1388
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Suzuki, Ayako; Barnhart, Huiman; Gu, Jiezhun et al. (2017) Associations of gender and a proxy of female menopausal status with histological features of drug-induced liver injury. Liver Int 37:1723-1730
Nicoletti, Paola; Aithal, Guruprasad P; Bjornsson, Einar S et al. (2017) Association of Liver Injury From Specific Drugs, or Groups of Drugs, With Polymorphisms in HLA and Other Genes in a Genome-Wide Association Study. Gastroenterology 152:1078-1089
Hayashi, Paul H; Rockey, Don C; Fontana, Robert J et al. (2017) Death and liver transplantation within 2 years of onset of drug-induced liver injury. Hepatology 66:1275-1285
Urban, Thomas Jacob; Nicoletti, Paola; Chalasani, Naga et al. (2017) Minocycline hepatotoxicity: Clinical characterization and identification of HLA-B?35:02 as a risk factor. J Hepatol 67:137-144
Navarro, Victor J; Khan, Ikhlas; Björnsson, Einar et al. (2017) Liver injury from herbal and dietary supplements. Hepatology 65:363-373
Whritenour, Jessica; Ko, Mira; Zong, Qing et al. (2017) Development of a modified lymphocyte transformation test for diagnosing drug-induced liver injury associated with an adaptive immune response. J Immunotoxicol 14:31-38

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