Trial Outcomes & Findings for POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study (NCT NCT02609841)

Results Overview

Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on \<3K dialysate. Hyperkalemia defined as serum potassium (S-K) \>5.0 mEq/L.

Recruitment status

COMPLETED

Target enrollment

240 participants

Primary outcome timeframe

12 Days

Results posted on

2017-07-25

Participant Flow

Patients with end stage renal disease on maintenance hemodialysis took part in the study at 17 sites in the United States.

Cardiac rhythm was monitored using a 24-hour non-invasive, wearable device (BodyGuardian® remote monitoring system) throughout the study to assess for cardiac arrhythmias was to be worn by patients. One site did not perform cardiac rhythm monitoring.

Participant milestones

Participant milestones
Measure	Enrolled Study Population All patients who were enrolled in the study
Overall Study STARTED	240
Overall Study COMPLETED	212
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	<3 K Dialysate Patients n=179 Participants Patients on \<3 K dialysate and received all 6 hemodialysis treatments over 12 days.	≥3K Dialysate Patients n=33 Participants Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days	Total n=212 Participants Total of all reporting groups
Age, Customized	56.9 Years STANDARD_DEVIATION 12.4 • n=5 Participants	58.5 Years STANDARD_DEVIATION 12.4 • n=7 Participants	57.1 Years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex/Gender, Customized Female	64 Participants n=5 Participants	13 Participants n=7 Participants	77 Participants n=5 Participants
Sex/Gender, Customized Male	115 Participants n=5 Participants	20 Participants n=7 Participants	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Days

Population: Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period

Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on \<3K dialysate. Hyperkalemia defined as serum potassium (S-K) \>5.0 mEq/L.

Outcome measures

Outcome measures
Measure	<3 K Dialysate Patients n=179 Participants Subjects on \<3 K dialysate and received all 6 hemodialysis treatments over 12 days.
Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients Any pre-dialysis HK after LIDP, %	50 Percent of participants
Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients Pre-dialysis HK after LIDP ( based on mean S-K), %	37 Percent of participants

SECONDARY outcome

Timeframe: 12 days

Population: Per protocol population

Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. Hyperkalemia defined as serum potassium (S-K) \>5.0 mEq/L.

Outcome measures

Outcome measures
Measure	<3 K Dialysate Patients n=33 Participants Subjects on \<3 K dialysate and received all 6 hemodialysis treatments over 12 days.
Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. Any pre-dialysis HK after LIDP, %	36 % of patients
Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. Pre-dialysis HK after LIDP ( based on mean S-K), %	21 % of patients

SECONDARY outcome

Timeframe: 12 days

Population: Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system

Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or \> 5 sec pause.

Outcome measures

Outcome measures
Measure	<3 K Dialysate Patients n=191 Participants Subjects on \<3 K dialysate and received all 6 hemodialysis treatments over 12 days.
Incidence of Cardiac Arrhythmias Atrial fibrillation	51 % of patients
Incidence of Cardiac Arrhythmias Serious arrhythmias	16 % of patients

Adverse Events

Cardiac Rhythm Monitoring System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

AstraZeneca Clinical Study Information Center

ZS Pharma, Inc.

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee ZS Pharma has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication
Publication restrictions are in place

Restriction type: OTHER