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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609841
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : June 23, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
ZS Pharma, Inc.

Brief 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.

Condition or disease Intervention/treatment
Hyperkalemia Device: Cardiac rhythm remote monitoring system

Detailed 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. 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.

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis (PORTEND): A Multicenter, Prospective, Observational Study
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Potassium

Group/Cohort Intervention/treatment
Cardiac rhythm remote monitoring system
Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
Device: Cardiac rhythm remote monitoring system
Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study.
Other Name: BodyGuardian




Primary Outcome Measures :
  1. Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients [ Time Frame: 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.


Secondary Outcome Measures :
  1. Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. [ Time Frame: 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.

  2. Incidence of Cardiac Arrhythmias [ Time Frame: 12 days ]
    Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects has ESRD and has been stable and compliant (as determined by the investigator) on 3 times weekly maintenance hemodialysis for at least 60 days.
Criteria

Inclusion Criteria:

  • Provision of written informed consent.
  • 18 years of age or older.
  • Subject has ESRD and has been stable and compliant (as determined by the investigator) on 3 times weekly maintenance hemodialysis for at least 60 days; 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. Dialysate K must be stable for 2 weeks prior to enrollment.
  • Hemoglobin > 9 g/dL.
  • Able to undergo peripheral venous sticks for blood draws on inter-dialysis days, or the dialysis/research team is able to use the dialysis access for blood draws on those days.
  • Subject or subject's caregiver at home can read and understand English and has the ability to use the BodyGuardian remote monitoring system.

Exclusion Criteria:

  • Pregnancy. Sexually active women of child-bearing potential must have a negative pregnancy test before starting the study on Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be a childbearing potential.
  • Subjects or bed partners with implanted pacemakers or defibrillators.
  • Known skin allergies or sensitivities to acrylic, hydrogel or silicone adhesives.
  • Fragile skin.
  • Participation in another clinical trial which may impact the results of this study.
  • Subjects who, in the opinion of investigator, are unable to perform the tasks associated with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609841


Locations
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United States, California
Los Angeles, California, United States, 90022
San Jose, California, United States, 95128
United States, Colorado
Denver, Colorado, United States, 80230
United States, Illinois
Evergreen Park, Illinois, United States, 60805
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Flushing, New York, United States, 11355
United States, Tennessee
Chattanooga, Tennessee, United States, 37408
United States, Texas
Lufkin, Texas, United States, 75904
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
ZS Pharma, Inc.
Investigators
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Study Chair: Henrik Rasmussen, MD, PhD ZS Pharma, Inc.

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Responsible Party: ZS Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02609841    
Other Study ID Numbers: ZS-008
First Posted: November 20, 2015    Key Record Dates
Results First Posted: June 23, 2017
Last Update Posted: July 25, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases