title: Closeout of the HALT-PKD trials.
abstract: BACKGROUND
  The HALT Polycystic Kidney Disease Trials Network consisted of two randomized, double blind, placebo-controlled trials among patients with autosomal dominant polycystic kidney disease. The trials involved 5-8years of participant follow-up with interventions in blood pressure and antihypertensive therapy. We provide a framework for designing and implementing closeout near the end of a trial while ensuring patient safety and maintaining scientific rigor and study morale.
  
  
  METHODS
  We discuss issues and resolutions for determining the last visit, tapering medications, and unblinding of participants to study allocation and results. We also discuss closure of clinical sites and Data Coordinating Center responsibilities to ensure timely release of study results and meeting the requirements of regulatory and funding authorities.
  
  
  RESULTS
  Just over 90% of full participants had a 6-month study visit prior to their last visit preparing them for trial closeout. Nearly all patients wanted notification of study results (99%) and treatment allocation (99%). All participants were safely tapered off study and open label blood pressure medications. Within 6months, the trials were closed, primary papers published, and 805 letters distributed to participants with results and allocation. DCC obligations for data repository and clinicaltrials.gov reporting were completed within 12months of the last study visit.
  
  
  CONCLUSIONS
  Closeout of our trials involved years of planning and significant human and financial resources. We provide questions for investigators to consider when planning closeout of their trials with focus on (1) patient safety, (2) dissemination of study results and (3) compliance with regulatory and funding responsibilities.
authors.affiliation: Carolinas HealthCare System, Charlotte, NC, USA. Electronic address: charity.patterson@carolinashealthcare.org.
authors.forename: Charity G
authors.initials: CG
authors.lastname: Moore
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Spillane
authors.affiliation: Tufts Medical Center, Boston, MA, USA.
authors.forename: Gertrude
authors.initials: G
authors.lastname: Simon
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Maxwell
authors.affiliation: Emory University, Atlanta, GA, USA.
authors.forename: Frederic F
authors.initials: FF
authors.lastname: Rahbari-Oskoui
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: William E
authors.initials: WE
authors.lastname: Braun
authors.affiliation: University of Chicago, Chicago, IL, USA.
authors.forename: Arlene B
authors.initials: AB
authors.lastname: Chapman
authors.affiliation: University of Colorado, Denver, CO, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Schrier
authors.affiliation: Mayo Clinic College of Medicine, Rochester, MN, USA.
authors.forename: Vicente E
authors.initials: VE
authors.lastname: Torres
authors.affiliation: Tufts Medical Center, Boston, MA, USA.
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Perrone
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Theodore I
authors.initials: TI
authors.lastname: Steinman
authors.affiliation: University of Colorado, Denver, CO, USA.
authors.forename: Godela
authors.initials: G
authors.lastname: Brosnahan
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Czarnecki
authors.affiliation: Mayo Clinic College of Medicine, Rochester, MN, USA.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Harris
authors.affiliation: Tufts Medical Center, Boston, MA, USA.
authors.forename: Dana C
authors.initials: DC
authors.lastname: Miskulin
authors.affiliation: The National Institutes of Health, Bethesda, MD, USA.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Flessner
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: K Ty
authors.initials: KT
authors.lastname: Bae
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Kaleab Z
authors.initials: KZ
authors.lastname: Abebe
authors.affiliation: Mayo Clinic College of Medicine, Rochester, MN, USA.
authors.forename: Marie C
authors.initials: MC
authors.lastname: Hogan
keywords: Closeout; Data coordination; Patient safety; Regulatory; Unblinding