? The Hemodialysis Fistula Maturation Consortium (HFMC) will conduct a prospective multi-center observational cohort study investigating factors associated with the failure of arteriovenous fistulas (AVFs) to mature. The Data Coordinating Center (DCC) will coordinate, administer, and support all HFMC research activities including all scientific and operational aspects of the Consortium. The DCC will: 1) assist in protocol development and analytical approaches for the protocol, and provide statistical leadership for study design; 2) develop data forms, instructions, and manuals of operations; 3) develop a data management and data collection system including an electronic communication system; 4) develop and maintain two web sites, one public and one for the research team; 5) establish, maintain and provide appropriate oversight to subcontracts for any central core laboratories as required; 6) work with the NIDDK Biosamples Repository and the clinical sites to coordinate procedures for coding, shipping, processing, receipt and storage of study samples to be maintained by the Repository; prepare the study data and coordinate with the NIDDK Data Repository for archiving; 7) develop procedures for quality control and training; 8) monitor the quality and quantity of data received from the clinical centers; 9) schedule, organize and perform site visits to clinical sites; 10) prepare periodic reports and analyses on recruitment, quality control, study adherence, patient safety and study results to the Steering Committee, the NIDDK and the Data, Safety and Monitoring Board; 11) support and coordinate manuscript publications and professional meeting presentations through data analysis, statistical collaboration and editorial support; 12) develop new statistical methodology as needed to properly analyze the data being collected; 13) schedule and arrange for all meetings and conference calls of established committees and boards; 14) provide regulatory guidance; and,15) provide overall scientific leadership. The goal of the HFMC is to identify pre-peri- and post-operative factors for AVF maturation and usability. Identification of risk factors for maturation failure and establishment of a surrogate for usability would facilitate the design of interventional trials targeting modifiable factors and help guide the clinical practice of whether and when to place AVF, and monitoring and implementing corrective actions for the AVF, thus improving hemodialysis patient lives. ? ?

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (M1))
Program Officer
Kusek, John W
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Cleveland Clinic Lerner
Internal Medicine/Medicine
Schools of Medicine
United States
Zip Code
Allon, Michael; Imrey, Peter B; Cheung, Alfred K et al. (2018) Relationships Between Clinical Processes and Arteriovenous Fistula Cannulation and Maturation: A Multicenter Prospective Cohort Study. Am J Kidney Dis 71:677-689
Robbin, Michelle L; Greene, Tom; Allon, Michael et al. (2018) Prediction of Arteriovenous Fistula Clinical Maturation from Postoperative Ultrasound Measurements: Findings from the Hemodialysis Fistula Maturation Study. J Am Soc Nephrol 29:2735-2744
Cheung, Alfred K; Imrey, Peter B; Alpers, Charles E et al. (2017) Intimal Hyperplasia, Stenosis, and Arteriovenous Fistula Maturation Failure in the Hemodialysis Fistula Maturation Study. J Am Soc Nephrol 28:3005-3013
van Ballegooijen, Adriana J; Zelnick, Leila; Hoofnagle, Andrew N et al. (2017) Association of Vitamin D Metabolites With Arterial Function in the Hemodialysis Fistula Maturation Study. Am J Kidney Dis 69:805-814
Alpers, Charles E; Imrey, Peter B; Hudkins, Kelly L et al. (2017) Histopathology of Veins Obtained at Hemodialysis Arteriovenous Fistula Creation Surgery. J Am Soc Nephrol 28:3076-3088
Robbin, Michelle L; Greene, Tom; Cheung, Alfred K et al. (2016) Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology 279:620-9
Allon, Michael; Greene, Tom; Dember, Laura M et al. (2016) Association between Preoperative Vascular Function and Postoperative Arteriovenous Fistula Development. J Am Soc Nephrol 27:3788-3795
Dember, Laura M; Imrey, Peter B; Duess, Mai-Ann et al. (2016) Vascular Function at Baseline in the Hemodialysis Fistula Maturation Study. J Am Heart Assoc 5:
Farber, Alik; Imrey, Peter B; Huber, Thomas S et al. (2016) Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. J Vasc Surg 63:163-70.e6
Dember, Laura M; Imrey, Peter B; Beck, Gerald J et al. (2014) Objectives and design of the hemodialysis fistula maturation study. Am J Kidney Dis 63:104-12