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

Not Applicable

Not yet recruiting

• Conditions: End Stage Kidney Disease

• Registration Number: NCT05558267
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Study Start: 2025-08-15
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period	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.
Change in Ambulatory Systolic Blood Pressure During First Treatment Period	Day 1, Day 16	Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).
Mean Potassium Concentration During First Treatment Period	Up to Day 16	Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Mean Potassium Concentration During Second Treatment Period	From Day 36 up to Day 52	Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period	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.
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period	Day 36, Day 52	Ambulatory systolic blood pressure expressed in mm Hg.
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period	Up to Day 16	Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.
Number of Participants Presenting with Moderate Hyperkalemia	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.
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period	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.
Number of Participants Presenting with Intradialytic Hypotension	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States