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

Completed

Conditions studied: Hyperkalemia

In brief

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.

Key facts

Study ID

NCT02609841

Run by

ZS Pharma, Inc.

People needed

240

Starts

2015-09-30

Expected to finish

2016-05-31

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Jose, California, United States
• Study site — Denver, Colorado, United States
• Study site — Evergreen Park, Illinois, United States
• Study site — Rochester, Minnesota, United States
• Study site — Flushing, New York, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Lufkin, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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