Back to resultsPotassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Primary Purpose
End Stage Kidney Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Table Salt
Salt Substitute
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Kidney Disease focused on measuring Potassium-Containing Salt Substitute
Eligibility Criteria
Inclusion Criteria:
- Receiving outpatient maintenance HD therapy.
- Age ≥ 21 years.
- Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.
Exclusion Criteria:
- Currently incarcerated.
- Insufficient capacity for informed consent.
- Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
- Unscheduled HD for hyperkalemia within ≤30 days.
- Attendance at ≤10 of last 13 scheduled OP HD sessions.
- Co-habiting family member with known hyperkalemia.
- Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
- Hemoglobin < 8.0 mg/dL.
- Use of other potassium supplements.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard Table Salt, then Salt Substitute
Salt Substitute, then Standard Table Salt
Arm Description
The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.
The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.
Outcomes
Primary Outcome Measures
Change in Serum Potassium Concentration During First Treatment Period
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Change in Serum Potassium Concentration During Second Treatment Period
Serum potassium concentration expressed in mEq/L.
Secondary Outcome Measures
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The first treatment period spans from Day 1 to Day 16.
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Moderate Hyperkalemia
Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.
Mean Potassium Concentration During First Treatment Period
Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Mean Potassium Concentration During Second Treatment Period
Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.
Change in Ambulatory Systolic Blood Pressure During First Treatment Period
Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
Ambulatory systolic blood pressure expressed in mm Hg.
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period
Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period
Pre-dialysis systolic blood pressure expressed in mm Hg. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Intradialytic Hypotension
Intradialytic hypotension defined as a systolic blood pressure of less than 100 mmHg or a systolic blood pressure decrease of greater than 10 mmHg, or a mean arterial pressure decrease of greater than 30 mmHg with or without symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05558267
Brief Title
Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Official Title
A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
Potassium-Containing Salt Substitute
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Table Salt, then Salt Substitute
Arm Type
Experimental
Arm Description
The two intervention periods will last 16 days with a 19-day washout period in between.
During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table.
Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing.
In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.
Arm Title
Salt Substitute, then Standard Table Salt
Arm Type
Experimental
Arm Description
The two intervention periods will last 16 days with a 19-day washout period in between.
During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table.
Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing.
In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Table Salt
Other Intervention Name(s)
Morton Standard Table Salt
Intervention Description
Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt Substitute
Other Intervention Name(s)
Morton Lite Salt
Intervention Description
Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt.
Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Primary Outcome Measure Information:
Title
Change in Serum Potassium Concentration During First Treatment Period
Description
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Time Frame
Day 1, Day 16
Title
Change in Serum Potassium Concentration During Second Treatment Period
Description
Serum potassium concentration expressed in mEq/L.
Time Frame
Day 36, Day 52
Secondary Outcome Measure Information:
Title
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
Description
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The first treatment period spans from Day 1 to Day 16.
Time Frame
Up to Day 16
Title
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
Description
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The second treatment period spans from Day 36 to Day 52.
Time Frame
From Day 36 up to Day 52
Title
Number of Participants Presenting with Moderate Hyperkalemia
Description
Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.
Time Frame
Up to Day 52
Title
Mean Potassium Concentration During First Treatment Period
Description
Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Time Frame
Up to Day 16
Title
Mean Potassium Concentration During Second Treatment Period
Description
Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.
Time Frame
From Day 36 up to Day 52
Title
Change in Ambulatory Systolic Blood Pressure During First Treatment Period
Description
Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).
Time Frame
Day 1, Day 16
Title
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
Description
Ambulatory systolic blood pressure expressed in mm Hg.
Time Frame
Day 36, Day 52
Title
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period
Description
Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.
Time Frame
Up to Day 16
Title
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period
Description
Pre-dialysis systolic blood pressure expressed in mm Hg. The second treatment period spans from Day 36 to Day 52.
Time Frame
From Day 36 up to Day 52.
Title
Number of Participants Presenting with Intradialytic Hypotension
Description
Intradialytic hypotension defined as a systolic blood pressure of less than 100 mmHg or a systolic blood pressure decrease of greater than 10 mmHg, or a mean arterial pressure decrease of greater than 30 mmHg with or without symptoms.
Time Frame
Up to Day 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving outpatient maintenance HD therapy.
Age ≥ 21 years.
Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.
Exclusion Criteria:
Currently incarcerated.
Insufficient capacity for informed consent.
Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
Unscheduled HD for hyperkalemia within ≤30 days.
Attendance at ≤10 of last 13 scheduled OP HD sessions.
Co-habiting family member with known hyperkalemia.
Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
Hemoglobin < 8.0 mg/dL.
Use of other potassium supplements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Charytan, MD MSc
Phone
617-935-1572
Email
David.charytan@Nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Rimler
Phone
631-357-1333
Email
Zoe.Rimler@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Charytan, MD MSc
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David Charytan, MD MSc (David.charytan@Nyulangone.org). The protocol will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.charytan@Nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
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