Evidence map›Paper›PMID 26231556›Full record

ArticleContemporary clinical trials2015

Closeout of the HALT-PKD trials.

Charity G Moore, Susan Spillane, Gertrude Simon, Barbara Maxwell, Frederic F Rahbari-Oskoui, William E Braun, Arlene B Chapman, Robert W Schrier, Vicente E Torres, Ronald D Perrone and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Charity G MooreCarolinas HealthCare System, Charlotte, NC, USA. Electronic address: charity.patterson@carolinashealthcare.org.
Susan SpillaneUniversity of Pittsburgh, Pittsburgh, PA, USA.
Gertrude SimonTufts Medical Center, Boston, MA, USA.
Barbara MaxwellBeth Israel Deaconess Medical Center, Boston, MA, USA.
Frederic F Rahbari-OskouiEmory University, Atlanta, GA, USA.
William E BraunCleveland Clinic, Cleveland, OH, USA.
Arlene B ChapmanUniversity of Chicago, Chicago, IL, USA.
Robert W SchrierUniversity of Colorado, Denver, CO, USA.
Vicente E TorresMayo Clinic College of Medicine, Rochester, MN, USA.
Ronald D PerroneTufts Medical Center, Boston, MA, USA.
Theodore I SteinmanBeth Israel Deaconess Medical Center, Boston, MA, USA.
Godela BrosnahanUniversity of Colorado, Denver, CO, USA.
Peter G CzarneckiBeth Israel Deaconess Medical Center, Boston, MA, USA.
Peter C HarrisMayo Clinic College of Medicine, Rochester, MN, USA.
Dana C MiskulinTufts Medical Center, Boston, MA, USA.
Michael F FlessnerThe National Institutes of Health, Bethesda, MD, USA.
K Ty BaeUniversity of Pittsburgh, Pittsburgh, PA, USA.
Kaleab Z AbebeUniversity of Pittsburgh, Pittsburgh, PA, USA.
Marie C HoganMayo Clinic College of Medicine, Rochester, MN, USA.

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
ZINC STATUS AND T CELL DISORDER IN MILD HUMAN ZINC DEFICIENCYM01RR001032 · NCRR · BETH ISRAEL DEACONESS MEDICAL CENTER · PI MANTZOROS, CHRISTOS S · 1985 to 2008
$32.3M
ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
NCATS NIH HHS UL1 TR000001NCATS NIH HHS UL1 TR000135NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001064NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001102NCRR NIH HHS M01 RR000039NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000054NCRR NIH HHS M01 RR000585NCRR NIH HHS M01 RR001032NCRR NIH HHS M01 RR023940NCRR NIH HHS UL1 RR024150NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1 RR025008NCRR NIH HHS UL1 RR025752NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1 RR033179NIDDK NIH HHS P30 DK090728NIDDK NIH HHS U01 DK062401NIDDK NIH HHS U01 DK062402NIDDK NIH HHS U01 DK062408NIDDK NIH HHS U01 DK062410NIDDK NIH HHS U01 DK062411NIDDK NIH HHS U01 DK082230
6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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.

resultsJust 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.

conclusionsCloseout 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.

Indexed as

CloseoutData coordinationPatient safetyRegulatoryUnblinding

Identifiers

PMID26231556
PMCPMC4732941

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.