Volume 7.0: November 2017

Transcription

1 Volume 7.0: November 2017 Chairman s Corner Dear RENAL AF investigators and coordinators, Thanks for an excellent investigator/ coordinator meeting at ASN. We had representation from approximately 10 study sites. We are eager to build on the momentum of now having 56 patients enrolled, having a protocol amendment that will make the trial better and easier, and having many of our steering committee now recently started or soon to begin enrollment. There was great interest in the data presented by Dr. Stanifer that provided support for the choice of the 5 mg dose of apixaban. Most importantly, it was clear that there is great energy, enthusiasm, and dedication in this core group to help assure that RENAL AF is a success so that patients may have the chance to benefit from advancing knowledge. Best regards, Glenn and Chris

2 Volume 7.0: November 2017 Trial Status as of 30 November 2017: Sites Activated Participants Randomized Actively Randomizing Centers Site # Principal Investigator Study Coordinator # Randomized 113 Piotr Lazowski, MD Alexandra Kennedy Sanjay Dalal, MD Brianna Johnson Amarnath Kathresal, MD Sherice Dove Erica Hopkins, MD Missi Mount Richard Miller, MD Melanie Haydel Moustafa A. Moustafa, MD Sandi Zurlo Frederick S. Fleszler, MD Stephanie Hanzl Jayant Kumar, MD Hemangini Shah Kendra Hendon, MD Diana Rios Donovan Polack, MD Pamela Pettiford Thomas Wooldridge, MD Alicia Butram Violet Habwe, MD Ehtisham Akhter Clarence Wheeler, MD Jenny Coleman Arnold Silva, MD Cathylee Sly Carlo G. Castillo, DO Jesslyn Roesch Mohamed A.K. Sekkarie, MD Randy Bailey Raja I. Zabaneh, MD Deanna Mondero Rekha Elizabeth John, MD Melissa Morgan Sourabh Prakash Kharait, MD Gaby Zumaran & Susan Mullins Elizabeth Bailey, MD Catherine Mack Kalyani Chandra, MD Gloria Partida 1

3 Volume 7.0: November 2017 Trial Status as of 30 November 2017: Activated Sites Pending Randomization Site # Principal Investigator Study Coordinator # Randomized 161 Alba Gonzalez Ochao, MD Patricia Flores Aurelio Ortiz, MD Ana Lopez Brian Mussio, MD Justine Galant Brigitte Schiller-Moran, MD Shelia Doss-McQuitty Douglas Shemin, MD Stephanie Warren Eugenia Galindo-Ramos, MD Amavelyn Rodriguez James Sullivan, MD Peggy Ann Lugo Jesus Navarro, MD Charles Phillips Joel Topf, MD Nicole Sonnenberg Manuel Montero, MD Morgan Moore Marializa Bernardo, MD Jezelle Josafat Michael Germain, MD Joy Whitbeck Pusadee Suchinda, MD Joyce Bilton Radu Jacob, MD Jill Livingston Saeed Joseph Kronfli, MD Ehtisham Akhter Sagar U. Nigwekar, MD Joshua Long V. Bala Subramanian, MD Ehtisham Akhter George Naratadam, MD Deborah Thompson Amit Arora, MD Deborah Thompson 0

4 SITE SPOTLIGHT Renal Medicine Associates Jayant Kumar, MD Principal Investigator and Hema Shah, Study Coordinator PI has been very active with the recruitment process, especially in identifying potential subjects. The study coordinators have also found much success with prescreening subjects, and then rounding with PI or sub-investigators at the dialysis units with potential candidates. The study coordinators perform extensive medical chart reviews of each of the facilities census using the dialysis center EMR and the office EMR. Study coordinators also run concomitant medication reports to identify the subjects that are currently prescribed an anticoagulant. Once potential subjects are identified the SC presents the clinical trial to them with brief overview of trial, what it entails, as well as the risks and the benefits. Once identified subjects have agreed to participate, the PI contacts the potential candidates PCP or Cardiologist. PI discusses the trial and determines if there are any potential risk or reasons why possible candidate should not participate in the study. We have found much success in enrolling for clinical trials at our site using this method.

5 DATA MANAGEMENT CORNER The study database has been updated to correspond with the protocol amendment and to improve functionality and clarity! Many changes will be noticeable by the site users. We are also updating the ecrf Instructions and will post them on the EDC RENAL AF Home page. Stay tuned! Visit / ecrf Month 4 and 5 Visits have been removed. Update Vital ecrf Weight has been clarified as Dry body weight or hemodialysis target body weight. Day 3-5 Visit Prior Warfarin and INR Page Name changed to Day 3 Visit, and allowable visit window is 3-6 days after randomization. Date of most recent dose of warfarin is only asked if the participant started within the last 30 days. Conmeds included on the ECRF within the follow-up visits: *Oral anti-arrhythmics: amiodarone, dronedarone, ranolazine Conmeds ecrf *Non-dihydropyridine calcium channel blocker *CYP3A4 section SAE Narrative *P-gp section Allows a much longer narrative entry before another page must be added (200 characters increased to 3700 characters). Pre-Screen Log Removed option for Previous Fall or High Risk of Future Fall.

6 COVANCE HOLIDAY SCHEDULE