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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac rhythm remote monitoring system | Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rhythm remote monitoring system | Device | Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Rasmussen, MD, PhD | ZS Pharma, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90022 | United States | |||
Cardiac rhythm was monitored using a 24-hour non-invasive, wearable device (BodyGuardian® remote monitoring system) throughout the study to assess for cardiac arrhythmias was to be worn by patients. One site did not perform cardiac rhythm monitoring.
Patients with end stage renal disease on maintenance hemodialysis took part in the study at 17 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Study Population | All patients who were enrolled in the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Incidence of Cardiac Arrhythmias |
Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause. |
| 12 days |
| San Jose |
| California |
| 95128 |
| United States |
| Denver | Colorado | 80230 | United States |
| Evergreen Park | Illinois | 60805 | United States |
| Rochester | Minnesota | 55905 | United States |
| Flushing | New York | 11355 | United States |
| Chattanooga | Tennessee | 37408 | United States |
| Lufkin | Texas | 75904 | United States |
| San Antonio | Texas | 78215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline data was summarized only for those patients who received all 6 hemodialysis (HD) treatments over 12 days; 28 patients did not complete all treatments and are excluded from baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | <3 K Dialysate Patients | Patients on <3 K dialysate and received all 6 hemodialysis treatments over 12 days. |
| BG001 | ≥3K Dialysate Patients | Patients on ≥3K dialysate who received all 6 hemodialysis treatments over 12 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period | Posted | Number | Percent of participants | 12 Days |
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| Secondary | Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. | 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. | Per protocol population | Posted | Number | % of patients | 12 days |
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| Secondary | Incidence of Cardiac Arrhythmias | Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause. | Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system | Posted | Number | % of patients | 12 days |
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Due to the observational nature of the study individual adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Rhythm Monitoring System | Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study. | 0 | 0 | 0 | 0 |
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ZS Pharma has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | ZS Pharma, Inc. | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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