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Cardiac rhythm remote monitoring system for Hyperkalemia (PORTEND Trial)

N/A
Waitlist Available
Research Sponsored by ZS Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 days
Awards & highlights
No Placebo-Only Group

Summary

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. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior to enrollment.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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients
Secondary study objectives
Incidence of Cardiac Arrhythmias
Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cardiac rhythm remote monitoring systemExperimental Treatment1 Intervention
Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac rhythm remote monitoring system
2015
N/A
~240

Find a Location

Who is running the clinical trial?

ZS Pharma, Inc.Lead Sponsor
7 Previous Clinical Trials
2,211 Total Patients Enrolled
7 Trials studying Hyperkalemia
2,211 Patients Enrolled for Hyperkalemia
Henrik Rasmussen, MD, PhDStudy ChairZS Pharma, Inc.
9 Previous Clinical Trials
2,014 Total Patients Enrolled
4 Trials studying Hyperkalemia
1,335 Patients Enrolled for Hyperkalemia
~24 spots leftby Oct 2025
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