Trial · NCT03781089

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

NCT03781089, Phase 4, Completed, Duke University; results first posted 2025-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients. Trials, record NCT03781089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03781089

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Trial

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

Title: Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
NCT number: NCT03781089
Status: Completed
Phases: Phase 4
Enrollment: 36 participants, actual
Lead sponsor: Duke University
Conditions: Hyperkalemia, End Stage Renal Disease
Interventions: Patiromer Oral Powder Product
First posted: 2018-12-19
Last updated: 2025-05-30
Results first posted: 2025-05-30

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L	Week 4	To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
Secondary	Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant	4 weeks	To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.
Secondary	Median Daily Dose of Patiromer That Was Given in Treatment Arm	Week 3
Secondary	Number of Additional Hemodialysis Treatments Due to Hyperkalemia	4 weeks	To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia
Secondary	Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Baseline	Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
Secondary	Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4	Week 4	Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but \< 30 seconds), \> 3 second pause), atrial fibrillation (\> 30 seconds), premature ventricular contractions \> 500/24h or bradycardia (heart rate \< 40 for 5 consecutive beats).
Secondary	Number of Participants Who Completed All Study Visits	4 weeks	To determine feasibility of a large-scale hemodialysis-based trial.
Secondary	Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours	4 weeks	PVCs are irregular contractions that start in the ventricles instead of the atria.
Secondary	Change in Serum Albumin Concentration	4 weeks	To determine the between-group differences in serum albumin concentrations.
Secondary	Change in Parathyroid Hormone (PTH) Concentration	4 weeks	To determine the between-group differences in PTH concentrations.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L	Week 4		episodes	NUMBER
SECONDARY	Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant	4 weeks		episodes per participant	MEDIAN
SECONDARY	Median Daily Dose of Patiromer That Was Given in Treatment Arm	Week 3	Not applicable to the Usual Care arm.	grams/day	MEDIAN
SECONDARY	Number of Additional Hemodialysis Treatments Due to Hyperkalemia	4 weeks	Data not collected. Post-dialysis serum potassium concentration was not measured, therefore unable to determine whether post-treatment hyperkalemia occurred.
SECONDARY	Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Baseline	One participant in Usual Care arm lost the cardiac monitor for week 4.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4	Week 4	One participant in Usual Care arm lost the cardiac monitor for week 4.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Completed All Study Visits	4 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours	4 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Serum Albumin Concentration	4 weeks	Data not collected due to limited resources.
SECONDARY	Change in Parathyroid Hormone (PTH) Concentration	4 weeks	Data not collected due to limited resources.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group25

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

Outcome	Group	Category	Value	Spread	Units
Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L	Patiromer Oral Powder Product		13		episodes
Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L	Usual Care Arm		41		episodes
Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant	Patiromer Oral Powder Product		0	Full Range 0 to 3	episodes per participant
Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant	Usual Care Arm		3	Full Range 0 to 6	episodes per participant
Median Daily Dose of Patiromer That Was Given in Treatment Arm	Patiromer Oral Powder Product		8.4	Standard Deviation 0	grams/day
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Patiromer Oral Powder Product	Premature ventricular contractions	4		Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Usual Care Arm	Premature ventricular contractions	2		Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Patiromer Oral Powder Product	Non-sustained VT events	2		Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Usual Care Arm	Non-sustained VT events	2		Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline	Patiromer Oral Powder Product	Atrial fibrillation	2		Participants

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Patiromer Oral Powder Product	17
Overall Study	STARTED	Usual Care Arm	16
Overall Study	COMPLETED	Patiromer Oral Powder Product	16
Overall Study	COMPLETED	Usual Care Arm	15
Overall Study	NOT COMPLETED	Patiromer Oral Powder Product	1
Overall Study	NOT COMPLETED	Usual Care Arm	1

Source ClinicalTrials.gov

Adverse events34

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
other	Parasthesias	Nervous system disorders	Patiromer Oral Powder Product	1	17
other	Parasthesias	Nervous system disorders	Usual Care Arm	0	16
other	Constipation	Gastrointestinal disorders	Patiromer Oral Powder Product	1	17
other	Constipation	Gastrointestinal disorders	Usual Care Arm	0	16
other	Itching	Skin and subcutaneous tissue disorders	Patiromer Oral Powder Product	1	17
other	Itching	Skin and subcutaneous tissue disorders	Usual Care Arm	0	16
other	Pain from permcath placement	Surgical and medical procedures	Patiromer Oral Powder Product	0	17
other	Pain from permcath placement	Surgical and medical procedures	Usual Care Arm	1	16
other	Skin sensitivity to Holter patch	Skin and subcutaneous tissue disorders	Patiromer Oral Powder Product	0	17
other	Skin sensitivity to Holter patch	Skin and subcutaneous tissue disorders	Usual Care Arm	1	16

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Patiromer Oral Powder Product	0	17
Total, all-cause mortality	Usual Care Arm	0	16
Total, other adverse events	Patiromer Oral Powder Product	5	17
Total, other adverse events	Usual Care Arm	5	16
Total, serious adverse events	Patiromer Oral Powder Product	2	17
Total, serious adverse events	Usual Care Arm	2	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32588430	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 comparisons4

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

Comparison	Source
Patiromer Oral Powder Product vs Usual Care Arm: Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours	Trial comparisons
Patiromer Oral Powder Product vs Usual Care Arm: Number of Participants Who Completed All Study Visits	Trial comparisons
Patiromer Oral Powder Product vs Usual Care Arm: deaths from any cause	Trial comparisons
Patiromer Oral Powder Product vs Usual Care Arm: serious adverse events	Trial comparisons

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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