Trial · NCT02285920

Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

NCT02285920, Phase 2, Completed, University of Pennsylvania; results first posted 2019-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial. Trials, record NCT02285920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02285920

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
NCT number: NCT02285920
Status: Completed
Phases: Phase 2
Enrollment: 129 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: End-Stage Renal Disease
Interventions: Spironolactone
First posted: 2014-11-07
Last updated: 2019-07-23
Results first posted: 2019-07-23

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety - Number of Participants With Serum Potassium >6.5 mEq/L	0 - 40 weeks	The number of participants who had serum potassium \>6.5 mEq/L was assessed by treatment arm.
Primary	Safety - Participants With Serious Hypotension	0 - 40 weeks	The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).
Primary	Study Drug Tolerability	0 - 36 weeks	Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.
Primary	Efficacy - Change in Mitral Annular E' Velocity	Baseline to 36 weeks	Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.
Primary	Feasibility of Conducting a Full-scale Mortality-powered Trial	0 - 40 weeks	An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.
Secondary	Safety - Number of Participants With Serious Hyperkalemia	0 - 40 weeks	Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy
Secondary	Safety - Hyperkalemia Requiring Adjustment in Treatment	0 - 40 weeks	Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication
Secondary	Safety - Inter- or Intra-dialytic Hypotension	0 - 40 weeks	Inter- or intra-dialytic hypotension defined as: 1. Inter-dialytic: systolic blood pressure \<90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room. 2. Intra-dialytic: systolic blood pressure \<80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period
Secondary	Safety - Cardiovascular Death	0 - 40 weeks	Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease
Secondary	Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)	Baseline - 36 weeks	Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety - Number of Participants With Serum Potassium >6.5 mEq/L	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety - Participants With Serious Hypotension	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Study Drug Tolerability	0 - 36 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Efficacy - Change in Mitral Annular E' Velocity	Baseline to 36 weeks	The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.	cm/second	MEAN
PRIMARY	Feasibility of Conducting a Full-scale Mortality-powered Trial	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety - Number of Participants With Serious Hyperkalemia	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety - Hyperkalemia Requiring Adjustment in Treatment	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety - Inter- or Intra-dialytic Hypotension	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety - Cardiovascular Death	0 - 40 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)	Baseline - 36 weeks	The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.	percent ejection fraction	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group128

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Safety - Number of Participants With Serum Potassium >6.5 mEq/L	Placebo	9	Participants
Safety - Number of Participants With Serum Potassium >6.5 mEq/L	Spironolactone 12.5 mg	4	Participants
Safety - Number of Participants With Serum Potassium >6.5 mEq/L	Spironolactone 25 mg	4	Participants
Safety - Number of Participants With Serum Potassium >6.5 mEq/L	Spironolactone 50 mg	8	Participants
Safety - Participants With Serious Hypotension	Placebo	0	Participants
Safety - Participants With Serious Hypotension	Spironolactone 12.5 mg	2	Participants
Safety - Participants With Serious Hypotension	Spironolactone 25 mg	0	Participants
Safety - Participants With Serious Hypotension	Spironolactone 50 mg	3	Participants
Study Drug Tolerability	Placebo	16	Participants
Study Drug Tolerability	Spironolactone 12.5 mg	5	Participants

1 to 10 of 128Source ClinicalTrials.gov

See all 128 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	51
Overall Study	STARTED	Spironolactone 12.5 mg	27
Overall Study	STARTED	Spironolactone 25 mg	26
Overall Study	STARTED	Spironolactone 50 mg	25
Overall Study	COMPLETED	Placebo	47
Overall Study	COMPLETED	Spironolactone 12.5 mg	23
Overall Study	COMPLETED	Spironolactone 25 mg	21
Overall Study	COMPLETED	Spironolactone 50 mg	24
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Spironolactone 12.5 mg	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events148

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Placebo	1	51	1
other	Anemia	Blood and lymphatic system disorders	Spironolactone 12.5 mg	1	27	6
other	Anemia	Blood and lymphatic system disorders	Spironolactone 25 mg	1	26	1
other	Anemia	Blood and lymphatic system disorders	Spironolactone 50 mg	3	25	4
other	Palpitations	Cardiac disorders	Placebo	0	51	0
other	Palpitations	Cardiac disorders	Spironolactone 12.5 mg	0	27	0
other	Palpitations	Cardiac disorders	Spironolactone 25 mg	1	26	1
other	Palpitations	Cardiac disorders	Spironolactone 50 mg	0	25	0
other	Vertigo	Ear and labyrinth disorders	Placebo	0	51	0
other	Vertigo	Ear and labyrinth disorders	Spironolactone 12.5 mg	1	27	1

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	51
Total, all-cause mortality	Spironolactone 12.5 mg	0	27
Total, all-cause mortality	Spironolactone 25 mg	2	26
Total, all-cause mortality	Spironolactone 50 mg	1	25
Total, other adverse events	Placebo	45	51
Total, other adverse events	Spironolactone 12.5 mg	24	27
Total, other adverse events	Spironolactone 25 mg	25	26
Total, other adverse events	Spironolactone 50 mg	23	25
Total, serious adverse events	Placebo	27	51
Total, serious adverse events	Spironolactone 12.5 mg	13	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33586138	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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