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

Study identifier:ZS-008

ClinicalTrials.gov identifier:NCT02609841

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Hyperkalemia

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

240

Study type

Observational

Age

18 Years +

Date

Study Start Date: 30 Sept 2015

Primary Completion Date: 31 May 2016

Study Completion Date: 31 May 2016

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Verification:

Verified 01 Jun 2017 by ZS Pharma, Inc.

Collaborators

Inclusion and exclusion criteria

This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days. Approximately 240 Subjects who meet the eligibility criteria and sign the informed consent form can be enrolled in the study, after which a subject number will be assigned. The number of subjects on 3K or higher dialysate will be limited to 60, with the remainder of the subjects on 1K or 2K dialysate. Baseline data will be collected including subject demographics, dialysis prescription, and symptom assessment. In addition, results of clinical laboratory tests and urea reduction ratio (URR), dialyzer clearance-time-volume of distribution of urea (Kt/V), and intact parathyroid hormone (PTH) obtained within the 4 weeks prior to the first dialysis treatment on Study Day 1 will be collected from regular monthly labs to establish baseline. Subjects will be assessed in the dialysis clinic/research center over a period of 12 days. Subjects will start the study on the first day of a given week’s dialysis regimen (ie, Monday or Tuesday). Subjects who are on a Monday, Wednesday, and Friday dialysis schedule will skip the Saturday visit, and subjects who are on a Tuesday, Thursday, and Saturday dialysis schedule will skip the Sunday visit during the 12-day study duration. Subjects will undergo blood collection at each visit, including 6 dialysis days and 5 inter-dialysis days. On dialysis days, blood samples will be collected immediately before and at the end of dialysis treatment. During the dialysis treatments on Study Days 1 and 3 only, additional blood samples will be obtained at 30 minutes and 1 hour (± 15 minutes) after the start of dialysis for chemistry. On inter-dialysis days, the dialysis clinic/research center will make an effort to collect blood samples at the same approximate time that dialysis treatment would have started on days of dialysis. Otherwise, samples may be collected when the subject is able to visit the dialysis clinic/research center. Vital signs including heart rate and blood pressure, and body weight will be collected at each visit. On dialysis days, both pre- and post-dialysis weights will be collected, along with vital signs obtained during dialysis. A specifically designed symptom assessment will also be performed at specified times throughout the study. The subjects will also undergo cardiac rhythm monitoring using a non-invasive, Food and Drug Administration cleared, wearable device (BodyGuardian® remote monitoring system) throughout the 12 days of participation in the study. This will be used to assess for cardiac arrhythmias, as well as to correlate S-K levels with signal-averaged, processed ECG.

Location

Denver, Colorado, United States, 80230

Location

San Antonio, Texas, United States, 78215

Location

Los Angeles, California, United States, 90022

Location

Chattanooga, Tennessee, United States, 37408

Location

San Jose, California, United States, 95128

Location

Lufkin, Texas, United States, 75904

Location

Evergreen Park, Illinois, United States, 60805

Location

Flushing, New York, United States, 11355

Arms	Assigned Interventions
Other: Cardiac rhythm remote monitoring system Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.	-

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with end stage renal disease on maintenance hemodialysis took part in the study at 17 sites in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Enrolled study population	All patients who were enrolled in the study

Participant Flow: Overall Study

	Enrolled study population
STARTED	240
COMPLETED	212
NOT COMPLETED	28

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Baseline data was summarized only for those patients who received all 6 hemodialysis (HD) treatments over 12 days; 28 patients did not complete all treatments and are excluded from baseline population.

Reporting Groups

	Description
<3 K dialysate patients	Patients on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.
≥3K dialysate patients	Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days

Baseline Measures

	<3 K dialysate patients	≥3K dialysate patients	Total
Number of Participants [units: Participants]	179	33	212
Gender, Customized [units: Participants]
Female	64	13	77
Male	115	20	135
Age, Customized [units: Years] Mean ± Standard Deviation	56.9 ± 12.4	58.5 ± 12.4	57.1 ± 12.5

Outcome Measures

1. Primary Outcome Measure: Incidence of pre-dialysis HK after the LIDP in <3K dialysate patients [ Time Frame: 12 Days ]

Measure Type	Primary
Measure Name	Incidence of pre-dialysis HK after the LIDP in <3K dialysate patients
Measure Description	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.
Time Frame	12 Days
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period

Reporting Groups

	Description
<3 K dialysate patients	Subjects on <3 K dialysate and received all 6 hemodialysis treatments over 12 days.

Measured Values

	<3 K dialysate patients
Number of Participants Analyzed [units:participants]	179
Incidence of pre-dialysis HK after the LIDP in <3K dialysate patients [units: Percent of participants]
Any pre-dialysis HK after LIDP, %	50
Pre-dialysis HK after LIDP ( based on mean S-K), %	37

No statistical analysis provided for Incidence of pre-dialysis HK after the LIDP in <3K dialysate patients

2. Secondary Outcome Measure: Incidence of pre-dialysis hyperkalemia (HK) after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. [ Time Frame: 12 days ]

Measure Type	Secondary
Measure Name	Incidence of pre-dialysis hyperkalemia (HK) after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate.
Measure Description	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.
Time Frame	12 days
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol population

Reporting Groups

	Description
≥3 K dialysate patients	Subjects on ≥3 K dialysate and received all 6 hemodialysis treatments over 12 days.

Measured Values

	≥3 K dialysate patients
Number of Participants Analyzed [units:participants]	33
Incidence of pre-dialysis hyperkalemia (HK) after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. [units: % of patients]
Any pre-dialysis HK after LIDP, %	36
Pre-dialysis HK after LIDP ( based on mean S-K), %	21

No statistical analysis provided for Incidence of pre-dialysis hyperkalemia (HK) after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate.

3. Secondary Outcome Measure: Incidence of cardiac arrhythmias [ Time Frame: 12 days ]

Measure Type	Secondary
Measure Name	Incidence of cardiac arrhythmias
Measure Description	Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.
Time Frame	12 days
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system

Reporting Groups

	Description
Completed the study and wore the Body Guardian	All subjects (<3 K dialysate or dialysate combined) who received all 6 hemodialysis treatments over 12 days and wore the Body Guardian device

Measured Values

	Completed the study and wore the Body Guardian
Number of Participants Analyzed [units:participants]	191
Incidence of cardiac arrhythmias [units: % of patients]
Atrial fibrillation	51
Serious arrhythmias	16

No statistical analysis provided for Incidence of cardiac arrhythmias

Serious Adverse Events

Time Frame	No text entered.
Additional Description	Due to the observational nature of the study individual adverse events were not collected.

Reporting Groups

	Description
Cardiac rhythm monitoring system	Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.

Serious Adverse Events

	Cardiac rhythm monitoring system
Total, serious adverse events
# participants affected / at risk	0/0

Other Adverse Events

Time Frame	No text entered.
Additional Description	Due to the observational nature of the study individual adverse events were not collected.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Cardiac rhythm monitoring system	Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.

Other Adverse Events

	Cardiac rhythm monitoring system
Total, other (not including serious) adverse events
# participants affected / at risk	0/0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	AstraZeneca Clinical Study Information Center
Organization:	ZS Pharma, Inc.
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Henrik Rasmussen

443-699-5230

hrasmussen@zspharma.com

Investigators

Principal Investigator

Henrik Rasmussen

ZS Pharma, Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Trial Results Summaries