Evidence map›Paper›PMID 30473139›Full record

Trial reportKidney international2019

Safety and cardiovascular efficacy of spironolactone in dialysis-dependent ESRD (SPin-D): a randomized, placebo-controlled, multiple dosage trial.

David M Charytan, Jonathan Himmelfarb, T Alp Ikizler, Dominic S Raj, Jesse Y Hsu, J Richard Landis, Amanda H Anderson, Adriana M Hung, Rajnish Mehrotra, Shailendra Sharma and 8 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Kidney international, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 11 pooled it
7.3field-weighted citation impact, top 2% of its field
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

64 citing papers in PubMed, 11 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
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  12. Trial
  13. The effect of spironolactone on diastolic function in haemodialysis patients.The international journal of cardiovascular imaging · 2021
    Trial
  14. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM guideline for the prevention, detection, evaluation and management of high blood pressure in adults: a commentary from the European Renal Best Practice (ERBP).Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Article
  15. Review
  16. Mineralocorticoid Receptor Antagonists in Dialysis.American journal of nephrology · 2026
    Review
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 1 country.

David M CharytanDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. Electronic address: dcharytan@bwh.harvard.edu.
Jonathan HimmelfarbKidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.
T Alp IkizlerDivision of Nephrology and Hypertension, Department of Medicine, and Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Dominic S RajDivision of Renal Diseases and Hypertension, George Washington University School of Medicine, Washington, District of Columbia, USA.
Jesse Y HsuDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
J Richard LandisDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Amanda H AndersonDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Adriana M HungDivision of Nephrology and Hypertension, Department of Medicine, and Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Rajnish MehrotraKidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.
Shailendra SharmaDivision of Renal Diseases and Hypertension, George Washington University School of Medicine, Washington, District of Columbia, USA.
Daniel E WeinerDivision of Nephrology, Tufts Medical Center, Boston, Massachusetts, USA.
Mark WilliamsRenal Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Marcelo DiCarliDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA; Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Hicham SkaliDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA; Cardiovascular Division, Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Paul L KimmelNational Institute of Diabetes Digestive and Kidney Diseases, Bethesda, Maryland, USA.
Alan S KligerDepartment of Medicine, Yale School of Medicine and Yale New Haven Health System, New Haven, Connecticut, USA.
Laura M DemberCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Renal, Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Hemodialysis Novel Therapies Consortium
Brigham and Women's Hospital · USUniversity of Pennsylvania · USGeorge Washington University · USUniversity of Washington · USVanderbilt University Medical Center · USNational Institute of Diabetes and Digestive and Kidney Diseases · USTufts Medical Center · USYale New Haven Health System · USBeth Israel Deaconess Medical Center · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Data Coordinating Center for Hemodialysis Pilot Studies ConsortiumU01DK099919 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M, LANDIS, J RICHARD · 2013 to 2018
$5.2M
Anti-Inflammatory Interventions in Maintenance Hemodialysis PatientsU01DK099923 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HIMMELFARB, JONATHAN, IKIZLER, TALAT ALP · 2013 to 2018
$2.6M
Aldosterone, nitric oxide, myocardial fibrosis, and capillary loss in ESRDU01DK096189 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI MCCAUSLAND, FINNIAN R · 2013 to 2017
$2.4M
Determinants of Hemodialysis AV Fistula MaturationU01DK082232 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2008 to 2012
$2.4M
Gut Microbiota and Atherosclerosis in ESRDU01DK099914 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI RAJ, DOMINIC S · 2013 to 2017
$1.9M
Dysmetabolism of Chronic Kidney Disease and Vascular HealthI01CX000982 · VA · VETERANS HEALTH ADMINISTRATION · PI HUNG, ADRIANA · 2015 to 2018
–
CSRD VA I01 CX000982NCATS NIH HHS UL1 TR001102NIDDK NIH HHS U01 DK082232NIDDK NIH HHS U01 DK096189NIDDK NIH HHS U01 DK099914NIDDK NIH HHS U01 DK099919NIDDK NIH HHS U01 DK099923
6 · The paper itself

Abstract

The safety and efficacy of spironolactone is uncertain in end-stage renal disease. We randomized 129 maintenance hemodialysis patients to placebo (n=51) or spironolactone 12.5 mg (n=27), 25 mg (n=26), or 50 mg (n=25) daily for 36 weeks in a double-blind, placebo-controlled, multiple dosage trial to assess safety, tolerability and feasibility and to explore cardiovascular efficacy. The primary safety endpoints were hyperkalemia (potassium > 6.5 mEq/L) and hypotension requiring emergency department visit or hospitalization. Diastolic function was assessed by Doppler echocardiography. 125 participants (97%) completed dose escalation, with no significant difference in permanent study drug discontinuation between the groups (27.5% in placebo versus 16.7% in the combined spironolactone groups and 28% in the 50 mg group). Hyperkalemia frequency was similar between spironolactone and placebo (0.49 versus 0.50 events per patient-year) but demonstrated a significant linear trend due primarily to an increased event rate at the 50 mg dose (0.89 events per patient-year). The primary hypotension outcome was infrequent and similar with spironolactone and placebo (0.11 versus 0 events per patient-year). Gynecomastia was rare and did not differ significantly between groups. Change in diastolic function was similar with spironolactone and placebo. Spironolactone appears safe in carefully monitored maintenance hemodialysis patients, but did not affect cardiovascular parameters in this small study. Hyperkalemia occurs more frequently as dosage increases to 50 mg daily.

Indexed as

AdultAgedAldosteroneCardiovascular DiseasesDiastoleDose-Response Relationship, DrugDouble-Blind MethodEchocardiography, DopplerFeasibility StudiesFemaleGynecomastiaHumansHyperkalemiaHypotensionKidney Failure, ChronicMaleAldosteroneMineralocorticoid Receptor AntagonistsPlacebosPotassiumSpironolactonehemodialysismineralocorticoid blockademultiple dosagerandomized controlled trial

Identifiers

PMID30473139
PMCPMC6431563
OpenAlexW2901393632

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.