The Center for Research on Health Care (CRHC) Data Center at the University of Pittsburgh proposes to coordinate data collection and management, study monitoring, training and quality control, and shared research services across sites as the Data Coordinating Center (DCC) for the HALT-Polycystic Kidney Disease (PKD) Trials. The HALT-PKD trials comprise 2 randomized clinical trials conducted at 7 clinical sites supported by a central imaging facility (also at the University of Pittsburgh), a drug distribution center, 2 central laboratories, and 3 outside contractors. The Consortium is governed by a Steering Committee with help from 9 subcommittees and is overseen by an External Advisory Committee/Data Safety and Monitoring Board. Study data and bio-specimens are deposited in 3 NIDDK repositories. In Study A, the effect of study medication on structural progression at 2 levels of BP control is assessed using a 2x2 factorial design. Study B compares ACE-I/ARB combination therapy with ACE-I monotherapy on the time to a 50 percent reduction of baseline estimated GFR, ESRD or death. The CRHC Data Center currently coordinates the CRISP II cohort (Consortium of Radiologic Imaging Studies of PKD), and we will apply our expertise in PKD and data management and analysis to: 1) develop a Web-based data management system that incorporates data tracking, entry, quality control, safety monitoring, and report generation; 2) organize trial communications, support recruitment and retention at each site, and coordinate and monitor the transfer of data, images, and bio-specimens; and 3) plan and conduct statistical analyses to support the aims of each study. Co-locating the DCC for CRISP II and HALT-PKD will enhance the efficiency of data management, pooling, and analyses that could lead to new hypotheses and spin-off study designs. Following the seamless transition of the CRISP II DCC to Pittsburgh, we rapidly developed a Web-based data management and entry system and will apply our prior experience in moving an existing DCC for an ongoing multisite trial to minimize downtime for HALT-PKD. The CRHC Data Center has PhD-level statisticians with expertise needed for this effort, including genetics and longitudinal analyses of correlated data. Data Center personnel also bring expertise in customized form design, on-demand study progress reporting, and site staff training. We are dedicated to completing our work in a timely fashion and respecting the needs of clinical PIs and HALT team. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK082230-01
Application #
7547370
Study Section
Special Emphasis Panel (ZDK1-GRB-N (M2))
Program Officer
Flessner, Michael Francis
Project Start
2008-09-15
Project End
2013-05-31
Budget Start
2008-09-15
Budget End
2009-05-31
Support Year
1
Fiscal Year
2008
Total Cost
$1,000,000
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Cornec-Le Gall, Emilie; Olson, Rory J; Besse, Whitney et al. (2018) Monoallelic Mutations to DNAJB11 Cause Atypical Autosomal-Dominant Polycystic Kidney Disease. Am J Hum Genet 102:832-844
Nowak, Kristen L; You, Zhiying; Gitomer, Berenice et al. (2018) Overweight and Obesity Are Predictors of Progression in Early Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 29:571-578
Cornec-Le Gall, Emilie; Chebib, Fouad T; Madsen, Charles D et al. (2018) The Value of Genetic Testing in Polycystic Kidney Diseases Illustrated by a Family With PKD2 and COL4A1 Mutations. Am J Kidney Dis 72:302-308
Brosnahan, Godela M; Abebe, Kaleab Z; Rahbari-Oskoui, Frederic F et al. (2017) Effect of Statin Therapy on the Progression of Autosomal Dominant Polycystic Kidney Disease. A Secondary Analysis of the HALT PKD Trials. Curr Hypertens Rev 13:109-120
Torres, Vicente E; Abebe, Kaleab Z; Schrier, Robert W et al. (2017) Dietary salt restriction is beneficial to the management of autosomal dominant polycystic kidney disease. Kidney Int 91:493-500
Irazabal, María V; Abebe, Kaleab Z; Bae, Kyongtae Ty et al. (2017) Prognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial. Nephrol Dial Transplant 32:1857-1865
Heyer, Christina M; Sundsbak, Jamie L; Abebe, Kaleab Z et al. (2016) Predicted Mutation Strength of Nontruncating PKD1 Mutations Aids Genotype-Phenotype Correlations in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol 27:2872-84
Porath, Binu; Gainullin, Vladimir G; Cornec-Le Gall, Emilie et al. (2016) Mutations in GANAB, Encoding the Glucosidase II? Subunit, Cause Autosomal-Dominant Polycystic Kidney and Liver Disease. Am J Hum Genet 98:1193-1207
Hogan, Marie C; Abebe, Kaleab; Torres, Vicente E et al. (2015) Liver involvement in early autosomal-dominant polycystic kidney disease. Clin Gastroenterol Hepatol 13:155-64.e6
Moore, Charity G; Spillane, Susan; Simon, Gertrude et al. (2015) Closeout of the HALT-PKD trials. Contemp Clin Trials 44:48-55

Showing the most recent 10 out of 17 publications