[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05558267":3,"trial-entities:NCT05558267":122,"trial-summary:NCT05558267":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":54,"sex":89,"minimum_age":90,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":95,"locations":98,"central_contacts":106,"overall_officials":116,"references":120,"see_also_links":121},"NCT05558267","22-00769","Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease","A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease","NOT_YET_RECRUITING","2027-06-15","2026-03","2026-03-12","2027-01-15","NYU Langone Health","OTHER",false,"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.",null,[19],"End Stage Kidney Disease",[21],"Potassium-Containing Salt Substitute","INTERVENTIONAL","PREVENTION",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"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.",[35,36],"Salt Substitute, then Standard Table Salt","Standard Table Salt, then Salt Substitute",[38],"Morton Standard Table Salt",{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"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.\n\nSalt 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.",[35,36],[44],"Morton Lite Salt",[46,50],{"measure":47,"description":48,"timeFrame":49},"Change in Serum Potassium Concentration During First Treatment Period","Serum potassium concentration expressed in milliequivalents per liter (mEq\u002FL).","Day 1, Day 16",{"measure":51,"description":52,"timeFrame":53},"Change in Serum Potassium Concentration During Second Treatment Period","Serum potassium concentration expressed in mEq\u002FL.","Day 36, Day 52",[55,59,63,67,70,73,76,79,82,86],{"measure":56,"description":57,"timeFrame":58},"Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period","Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq\u002FL. The first treatment period spans from Day 1 to Day 16.","Up to Day 16",{"measure":60,"description":61,"timeFrame":62},"Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period","Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq\u002FL. The second treatment period spans from Day 36 to Day 52.","From Day 36 up to Day 52",{"measure":64,"description":65,"timeFrame":66},"Number of Participants Presenting with Moderate Hyperkalemia","Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq\u002FL and less than 6.5 mEq\u002FL.","Up to Day 52",{"measure":68,"description":69,"timeFrame":58},"Mean Potassium Concentration During First Treatment Period","Potassium concentration expressed in mEq\u002FL. The first treatment period spans from Day 1 to Day 16.",{"measure":71,"description":72,"timeFrame":62},"Mean Potassium Concentration During Second Treatment Period","Potassium concentration expressed in mEq\u002FL. The second treatment period spans from Day 36 to Day 52.",{"measure":74,"description":75,"timeFrame":49},"Change in Ambulatory Systolic Blood Pressure During First Treatment Period","Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).",{"measure":77,"description":78,"timeFrame":53},"Change in Ambulatory Systolic Blood Pressure During Second Treatment Period","Ambulatory systolic blood pressure expressed in mm Hg.",{"measure":80,"description":81,"timeFrame":58},"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.",{"measure":83,"description":84,"timeFrame":85},"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.",{"measure":87,"description":88,"timeFrame":66},"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.","ALL","21 Years",{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\n1. Receiving outpatient maintenance HD therapy.\n2. Age ≥ 21 years.\n3. Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.\n\nExclusion Criteria:\n\n1. Currently incarcerated.\n2. Insufficient capacity for informed consent.\n3. Non-hemolyzed serum potassium concentration \\>6.0 mEq\u002FL within ≤30 days.\n4. Unscheduled HD for hyperkalemia within ≤30 days.\n5. Attendance at ≤10 of last 13 scheduled OP HD sessions.\n6. Co-habiting family member with known hyperkalemia.\n7. Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.\n8. Hemoglobin \\\u003C 8.0 mg\u002FdL.\n9. Use of other potassium supplements.",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":13,"city":100,"state":100,"zip":101,"country":102,"geoPoint":103},"New York","10016","United States",{"lat":104,"lon":105},40.71427,-74.00597,[107,112],{"name":108,"role":109,"phone":110,"email":111},"David Charytan, MD MSc","CONTACT","617-935-1572","David.charytan@Nyulangone.org",{"name":113,"role":109,"phone":114,"email":115},"Zoe Rimler","631-357-1333","Zoe.Rimler@nyulangone.org",[117],{"name":108,"affiliation":118,"role":119},"NYU Langone Medical Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":127,"summary":128,"prompt_version":138},true,{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This interventional study involves 16 participants who will receive both a potassium-containing salt substitute and standard table salt in a random order.","completed","Potassium-Containing Salt-Substitute in End Stage Kidney Disease","This study is looking at how a special salt substitute affects potassium levels in people with end-stage kidney disease who are on hemodialysis. The salt substitute has about 50% less sodium than regular table salt because it uses potassium chloride instead of sodium chloride. You would try both the Salt Substitute and Standard Table Salt for 16 days each, with a break in between. Researchers will measure your potassium levels to see if the salt substitute changes them. They will also look at your diet, blood pressure, and any symptoms you might have. To join, you need to be at least 21 years old and receiving outpatient hemodialysis. Your serum potassium level must not be above 6. The study plans to enroll 20 participants, but the current status of enrollment is unclear.","Potassium levels will be measured during the two 16-day treatment periods, with measurements at Day 1, Day 16, Day 36, and Day 52.",132,"You would use the Salt Substitute for 16 days and Standard Table Salt for 16 days, with a 19-day break in between. Potassium levels will be measured twice a week before your dialysis sessions.","Not stated in the trial record.",[32,40],"v2"]