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

NCT05558267 | Not Yet Recruiting

• 1 other identifier: 22-00769
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Kidney Disease

Keywords

Potassium-Containing Salt Substitute

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period

  Up to Day 16

• Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period

  From Day 36 up to Day 52

• Number of Participants Presenting with Moderate Hyperkalemia

  Up to Day 52

• Mean Potassium Concentration During First Treatment Period

  Up to Day 16

• Mean Potassium Concentration During Second Treatment Period

  From Day 36 up to Day 52

Study Arms (2)

Standard Table Salt, then Salt Substitute

EXPERIMENTAL

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; Dietary Supplement: Salt Substitute

Salt Substitute, then Standard Table Salt

EXPERIMENTAL

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; Dietary Supplement: Salt Substitute

Interventions

Standard Table Salt DIETARY_SUPPLEMENT

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.

Also known as: Morton Standard Table Salt

Salt Substitute, then Standard Table Salt; Standard Table Salt, then Salt Substitute

Salt Substitute DIETARY_SUPPLEMENT

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.

Also known as: Morton Lite Salt

Salt Substitute, then Standard Table Salt; Standard Table Salt, then Salt Substitute

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Charytan, MD MSc

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Charytan, MD MSc

CONTACT

617-935-1572; David.charytan@Nyulangone.org

Zoe Rimler

CONTACT

631-357-1333; Zoe.Rimler@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)