NCT02609841 (PORTEND) is a clinical trial of Cardiac rhythm remote monitoring system in Hyperkalemia, sponsored by ZS Pharma, Inc..

Who is sponsoring NCT02609841?

NCT02609841 is sponsored by ZS Pharma, Inc..

What drugs are being tested in NCT02609841?

Interventions in NCT02609841: Cardiac rhythm remote monitoring system.

What condition does NCT02609841 study?

NCT02609841 studies Hyperkalemia.

Is NCT02609841 still recruiting?

NCT02609841 is currently completed. Last updated 25 July 2017.

Are results published for NCT02609841?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-07-25 · How we verify

NCT02609841: PORTEND

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 25 July 2017

What this trial tests

trial testing Cardiac rhythm remote monitoring system in Hyperkalemia in 240 participants. Completed in 31 May 2016.

Timeline

30 September 2015

Primary endpoint
31 May 2016

31 May 2016

Quick facts

Lead sponsor	ZS Pharma, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	240
Start date	30 September 2015
Primary completion	31 May 2016
Estimated completion	31 May 2016
Sites	9 locations across United States

Drugs / interventions tested

Cardiac rhythm remote monitoring system

Conditions studied

Hyperkalemia — all drugs for Hyperkalemia →

Sponsor

ZS Pharma, Inc. — full company profile →

Who can join

18 and older, any sex, with Hyperkalemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients Primary · 12 Days

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.

Any pre-dialysis HK after LIDP, %

Group	Value	95% CI
<3 K Dialysate Patients	50

Pre-dialysis HK after LIDP ( based on mean S-K), %

Group	Value	95% CI
<3 K Dialysate Patients	37

Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. Secondary · 12 days

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.

Any pre-dialysis HK after LIDP, %

Group	Value	95% CI
≥3 K Dialysate Patients	36

Pre-dialysis HK after LIDP ( based on mean S-K), %

Group	Value	95% CI
≥3 K Dialysate Patients	21

Incidence of Cardiac Arrhythmias Secondary · 12 days

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

Atrial fibrillation

Group	Value	95% CI
Completed the Study and Wore the Body Guardian	51

Serious arrhythmias

Group	Value	95% CI
Completed the Study and Wore the Body Guardian	16

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hyperkalemia

Currently open trials in the same condition.

NCT06366230 — Adding Urea to the Final Dialysis Fluid · Phase 1, PHASE2 · recruiting
NCT06884267 — Hyperkalemia Quality Improvement Program (HK-QIP) Study · NA · recruiting
NCT06940414 — Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community · recruiting
NCT05766839 — Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age · Phase 2 · recruiting
NCT06365684 — Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 · Phase 4 · recruiting

Other ZS Pharma, Inc. trials

Trials by the same sponsor.

NCT02607085 — REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study · completed
NCT02163499 — Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months · Phase 3 · completed
NCT02107092 — Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. · Phase 3 · completed
NCT02088073 — Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia. · Phase 3 · completed
NCT01737697 — Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02609841 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ZS Pharma, Inc.
Last refreshed: 25 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02609841.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing