NCT00328809 is a Phase 4 clinical trial of spironolactone in End Stage Renal Disease, sponsored by State University of New York - Upstate Medical University.

Who is sponsoring NCT00328809?

NCT00328809 is sponsored by State University of New York - Upstate Medical University.

What drugs are being tested in NCT00328809?

Interventions in NCT00328809: spironolactone.

What condition does NCT00328809 study?

NCT00328809 studies End Stage Renal Disease, Congestive Heart Failure.

Is NCT00328809 still recruiting?

NCT00328809 is currently withdrawn. Last updated 22 October 2020.

Last reviewed 2020-10-22 · How we verify

NCT00328809

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Spironolactone Safety in Dialysis Patients

Withdrawn Phase 4 Last updated 22 October 2020

What this trial tests

Phase 4 trial testing spironolactone in End Stage Renal Disease. Withdrawn.

Timeline

30 June 2013

Primary endpoint
30 June 2017

24 September 2019

Quick facts

Lead sponsor	State University of New York - Upstate Medical University
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 June 2013
Primary completion	30 June 2017
Estimated completion	24 September 2019
Sites	1 location across United States

Drugs / interventions tested

spironolactone (spironolactone) — full drug profile →

Conditions studied

End Stage Renal Disease — all drugs for End Stage Renal Disease →
Congestive Heart Failure — all drugs for Congestive Heart Failure →

Sponsor

State University of New York - Upstate Medical University

Who can join

18 and older, any sex, with End Stage Renal Disease or Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Aldosterone antagonists for people with chronic kidney disease requiring dialysis.
Hasegawa T, Nishiwaki H, Ota E, Levack WM, et al · · 2021 · cited 22× · PMID 33586138 · DOI 10.1002/14651858.cd013109.pub2

Verify or expand the search:

Other trials of spironolactone

Trials testing the same drug.

NCT07137364 — Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism · recruiting
NCT03334682 — Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman. · Phase 3 · completed
NCT04495712 — Antiarrhythmic Effects of Spironolactone in Patients With ICDs · Phase 4 · completed

Other recruiting trials for End Stage Renal Disease

Currently open trials in the same condition.

NCT06257134 — Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients. · NA · recruiting
NCT06310161 — Light Therapy in End Stage Kidney Disease · NA · recruiting
NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
NCT06422871 — PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis · recruiting
NCT06861816 — Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs · NA · recruiting

Other State University of New York - Upstate Medical University trials

Trials by the same sponsor.

NCT07220031 — Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay · not yet recruiting
NCT04736953 — Sirolimus Treatment Of Patients With SLE · Phase 2 · not yet recruiting
NCT06045650 — Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder · not yet recruiting
NCT06370442 — Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult · Phase 3 · not yet recruiting
NCT05967455 — Homologous Re-infection With Dengue 1 or Dengue 3 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00328809 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by State University of New York - Upstate Medical University
Last refreshed: 22 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00328809.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing