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NCT Number: NCT05558267

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Morton Standard Table Salt

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.

Other names: Morton Lite Salt

Primary outcomes

  1. Change in Serum Potassium Concentration During First Treatment Period

    Time frame: Day 1, Day 16

    Serum potassium concentration expressed in milliequivalents per liter (mEq/L).

  2. Change in Serum Potassium Concentration During Second Treatment Period

    Time frame: Day 36, Day 52

    Serum potassium concentration expressed in mEq/L.

Secondary outcomes

  1. Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period

    Time frame: Up to Day 16

    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.

  2. Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period

    Time frame: From Day 36 up to Day 52

    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.

  3. Number of Participants Presenting with Moderate Hyperkalemia

    Time frame: Up to Day 52

    Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.

  4. Mean Potassium Concentration During First Treatment Period

    Time frame: Up to Day 16

    Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.

  5. Mean Potassium Concentration During Second Treatment Period

    Time frame: From Day 36 up to Day 52

    Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.

  6. Change in Ambulatory Systolic Blood Pressure During First Treatment Period

    Time frame: Day 1, Day 16

    Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).

  7. Change in Ambulatory Systolic Blood Pressure During Second Treatment Period

    Time frame: Day 36, Day 52

    Ambulatory systolic blood pressure expressed in mm Hg.

  8. Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period

    Time frame: Up to Day 16

    Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.

  9. Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period

    Time frame: From Day 36 up to Day 52.

    Pre-dialysis systolic blood pressure expressed in mm Hg. The second treatment period spans from Day 36 to Day 52.

  10. Number of Participants Presenting with Intradialytic Hypotension

    Time frame: Up to Day 52

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Charytan, MD MSc

CONTACT

[email protected]

617-935-1572

Zoe Rimler

CONTACT

[email protected]

631-357-1333

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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