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

End Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558267
• Other study ID #: 22-00769
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 29, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: David Charytan, MD MSc
• Phone: 617-935-1572
• Email: David.charytan[@]Nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Potassium Concentration During First Treatment Period	Serum potassium concentration expressed in milliequivalents per liter (mEq/L).	Day 1, Day 16
Primary	Change in Serum Potassium Concentration During Second Treatment Period	Serum potassium concentration expressed in mEq/L.	Day 36, Day 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Ambulatory Systolic Blood Pressure During Second Treatment Period	Ambulatory systolic blood pressure expressed in mm Hg.	Day 36, Day 52
Secondary	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
Secondary	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.
Secondary	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