End Stage Kidney DiseaseNCT05558267
Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
A study testing Standard Table Salt and Salt Substitute in people with End Stage Kidney Disease, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Standard Table Salt and Salt Substitute
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- End Stage Kidney Disease
- Being tested
- Standard Table Salt, Salt Substitute
- Keywords
- Potassium-Containing Salt Substitute
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Table SaltDietary supplement
Also called Morton 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 SubstituteDietary supplement
Also called Morton Lite Salt
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Standard Table Salt; Dietary Supplement: Salt Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium Concentration During First Treatment Period
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Measured: Day 1, Day 16
Change in Serum Potassium Concentration During Second Treatment Period
Serum potassium concentration expressed in mEq/L.
Measured: Day 36, Day 52
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 1, Day 16
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
Ambulatory systolic blood pressure expressed in mm Hg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charytan, MD MSc, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558267
- Sponsor's protocol ID
- 22-00769
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT05558267
- Acronym / sponsor ID
- 22-00769
- Conditions
- End Stage Kidney Disease
- Keywords
- Potassium-Containing Salt Substitute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Table Salt, then Salt Substitute | Experimental | Dietary Supplement: Standard Table Salt, Dietary Supplement: Salt SubstituteThe 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. |
| Salt Substitute, then Standard Table Salt | Experimental | Dietary Supplement: Standard Table Salt, Dietary Supplement: Salt SubstituteThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Table SaltAlso: Morton Standard Table SaltStandard 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. | Dietary supplement | Salt Substitute, then Standard Table Salt, Standard Table Salt, then Salt Substitute |
| Salt SubstituteAlso: Morton Lite SaltSalt 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. | Dietary supplement | Salt Substitute, then Standard Table Salt, Standard Table Salt, then Salt Substitute |
Primary outcome
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).
Change in Serum Potassium Concentration During Second Treatment Period
Time frame: Day 36, Day 52
Serum potassium concentration expressed in mEq/L.
10 secondary outcomes
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
Time frame: Up to Day 16
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
Time frame: From Day 36 up to Day 52
Number of Participants Presenting with Moderate Hyperkalemia
Time frame: Up to Day 52
Mean Potassium Concentration During First Treatment Period
Time frame: Up to Day 16
Mean Potassium Concentration During Second Treatment Period
Time frame: From Day 36 up to Day 52
Change in Ambulatory Systolic Blood Pressure During First Treatment Period
Time frame: Day 1, Day 16
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
Time frame: Day 36, Day 52
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period
Time frame: Up to Day 16
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period
Time frame: From Day 36 up to Day 52.
Number of Participants Presenting with Intradialytic Hypotension
Time frame: Up to Day 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Charytan, MD MSc principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Table Salt and Salt Substitute in people with End Stage Kidney Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Charytan, MD MSc (617-935-1572, David.charytan@Nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Potassium Concentration During First Treatment Period (time frame: Day 1, Day 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.