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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed 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. 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 collec
Sponsor: ZS Pharma, Inc.

Current Primary Outcome: Incidence of pre-dialysis hyperkalemia during the long inter-dialytic intervals [ Time Frame: 12 days ]

The incidence of pre-dialysis hyperkalemia during the long inter-dialytic intervals (using the mean pre-dialysis central lab potassium from Study Day 1 and Study Day 8) in subjects on <3K dialysate.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of pre-dialysis hyperkalemia during the long inter-dialytic intervals stratified based on dialysate [ Time Frame: 12 days ]

The incidence of pre-dialysis hyperkalemia during the long inter-dialytic intervals (using the mean pre-dialysis central lab potassium from Study Day 1 and Study Day 8) in subjects on 3K or higher dialysate.


Original Secondary Outcome: Same as current

Information By: ZS Pharma, Inc.

Dates:
Date Received: November 17, 2015
Date Started: September 2015
Date Completion:
Last Updated: June 6, 2016
Last Verified: June 2016