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Frequent Hemodialysis Network Data Coordinating Center

Award Number: U01DK066597
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2003
PERIOD OF PERFORMANCE END DATE: 06/30/2014

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Frequent Hemodialysis Network Data Coordinating Center - DESCRIPTION (provided by applicant): The Data Coordinating Center (DCC) for the Frequent Hemodialysis Network (FHN) will continue to coordinate the scientific and operational aspects of the two FHN clinical trials: one comparing short in-center 6x/week dialysis with conventional 3x/week dialysis and one comparing long home nocturnal 6x/week dialysis with home conventional 3x/week dialysis. During the on-going recruitment and follow-up of each FHN trial, the DCC will monitor patient recruitment and compliance as a whole and by clinical center. The database management system previously developed is used to assure accurate and complete collection of trial data. An inquiry system is used to resolve data discrepancies. The DCC will continue to make changes as necessary in the forms, database, manuals of operation, FHN web site, and reports. Many of the interactions with the clinical investigators are done through the work of subcommittees. The DCC will provide yearly centralized training of clinical center staff on the entry of trial patients, the completion of trial forms, and the use of the data management system. The DCC will promote adherence to the trial protocols. Site visit calls or visits to the clinical centers are made as necessary. Trial progress is given in reports to the clinical centers, Steering Committee, and Data Safety and Monitoring Board. Statistical analyses are performed during the course of each trial with final outcome analyses completed and reported at the end of each trial. The DCC handles the planning of meetings and conference calls, and administrative tasks. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Biological specimens and trial data (at end) are transferred to NIDDK repositories. Since the FHN is a multi-centered effort on two trials, the DCC will provide leadership to coordinate each trial's conduct to optimize resources and gain efficiencies. The DCC will work to foster a spirit of cooperation, which is important in this network. Results from the FHN trials will lead to a better understanding of more frequent hemodialysis beyond the conventional 3x/week and its impact on many outcomes affecting the health and well-being of hemodialysis patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2011	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	2/25/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $0 )
2013	2011	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	4/23/2013	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2011 ( Subtotal = $0 )
2011	2011	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	8/30/2011	NON-COMPETING CONTINUATION	-$599,917
2011	2011	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	4/8/2011	NON-COMPETING CONTINUATION	$599,917
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $619,999 )
2010	2010	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44195	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	001	7	6/23/2010	NON-COMPETING CONTINUATION	$619,999
2010	2009	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	6	2/1/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $619,999

Issue Date FY: 2009 ( Subtotal = $1,208,503 )
2009	2009	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44195	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	001	6	7/29/2009	NON-COMPETING CONTINUATION	$873,503
2009	2009	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44195	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	9/25/2009	SUPPLEMENT FOR EXPANSION	$335,000
2009	2008	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	5	6/30/2009	COMPETING CONTINUATION	$0
														Subtotal = $1,208,503

Issue Date FY: 2008 ( Subtotal = $1,167,694 )
2008	2008	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	5	8/25/2008	COMPETING CONTINUATION	$1,167,694
														Subtotal = $1,167,694

Issue Date FY: 2006 ( Subtotal = $995,000 )
2006	2006	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	4	9/25/2006	NON-COMPETING CONTINUATION	$995,000
														Subtotal = $995,000

Issue Date FY: 2004 ( Subtotal = $799,744 )
2004	2004	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	2	9/20/2004	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$712,744
2004	2004	CWRU-CLEVELAND CLINIC LERNER COLLEGE	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	001	2	9/20/2004	SUPPLEMENT FOR EXPANSION	$87,000
														Subtotal = $799,744

Issue Date FY: 2003 ( Subtotal = $487,000 )
2003	2003	CLEVELAND CLINIC FOUNDATION	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	000	1	9/19/2003	NEW	$400,000
2003	2003	CLEVELAND CLINIC FOUNDATION	9500 EUCLID AVENUE	CLEVELAND	OH	44106	CUYAHOGA	USA	Kidney Diseases, Urology and Hematology Research	001	1	9/29/2003	SUPPLEMENT FOR EXPANSION	$87,000
														Subtotal = $487,000

Grand Total All Awards = $5,277,940

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Frequent Hemodialysis Network Data Coordinating Center

Award Number: U01DK066597

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2003

PERIOD OF PERFORMANCE END DATE: 06/30/2014

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