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

NCT02609841 | Completed Results FDA Device

• 1 other identifier: ZS-008
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 9

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients

  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.

  12 Days

Secondary Outcomes (2)

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

  12 days

• Incidence of Cardiac Arrhythmias

  12 days

Study Arms (1)

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

Interventions

Cardiac rhythm remote monitoring system DEVICE

Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study.

Also known as: BodyGuardian

Cardiac rhythm remote monitoring system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Provision of written informed consent.
• 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.

Sponsors & Collaborators

• ZS Pharma, Inc.: lead

Study Sites (9)

Unknown Facility

Los Angeles, California, 90022, United States

Location

Unknown Facility

San Jose, California, 95128, United States

Location

Unknown Facility

Denver, Colorado, 80230, United States

Location

Unknown Facility

Evergreen Park, Illinois, 60805, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Flushing, New York, 11355, United States

Location

Unknown Facility

Chattanooga, Tennessee, 37408, United States

Location

Unknown Facility

Lufkin, Texas, 75904, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: ZS Pharma, Inc.

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Henrik Rasmussen, MD, PhD

  ZS Pharma, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: September 30, 2015
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: July 25, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-06

Locations

US (9)