Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Dietary supplement: Standard Table Salt; Dietary supplement: Salt Substitute

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Charytan, MD MSc; Phone Number: 617-935-1572; Email: David.charytan@Nyulangone.org
• Study Contact Backup: Name: Zoe Rimler; Phone Number: 631-357-1333; Email: Zoe.Rimler@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Receiving outpatient maintenance HD therapy.
2. Age ≥ 21 years.
3. Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.

Exclusion Criteria:

1. Currently incarcerated.
2. Insufficient capacity for informed consent.
3. Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
4. Unscheduled HD for hyperkalemia within ≤30 days.
5. Attendance at ≤10 of last 13 scheduled OP HD sessions.
6. Co-habiting family member with known hyperkalemia.
7. Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
8. Hemoglobin < 8.0 mg/dL.
9. Use of other potassium supplements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Table Salt, then Salt Substitute; 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.	Dietary supplement: Standard Table Salt; 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.; Other Names: Morton Standard Table Salt; Dietary supplement: Salt Substitute; 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.; Other Names: Morton Lite Salt
Experimental: Salt Substitute, then Standard Table Salt; 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.	Dietary supplement: Standard Table Salt; 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.; Other Names: Morton Standard Table Salt; Dietary supplement: Salt Substitute; 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.; Other Names: Morton Lite Salt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Potassium Concentration During First Treatment Period	Serum potassium concentration expressed in milliequivalents per liter (mEq/L).	Day 1, Day 16
Change in Serum Potassium Concentration During Second Treatment Period	Serum potassium concentration expressed in mEq/L.	Day 36, Day 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up 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.	From Day 36 up 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.	Up to Day 52
Mean Potassium Concentration During First Treatment Period	Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.	Up 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.	From Day 36 up to Day 52
Change in Ambulatory Systolic Blood Pressure During First Treatment Period	Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).	Day 1, Day 16
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period	Ambulatory systolic blood pressure expressed in mm Hg.	Day 36, Day 52
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.	Up 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.	From Day 36 up 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.	Up to Day 52

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Charytan, MD MSc, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 29, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Potassium-Containing Salt Substitute
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 22-00769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No