Active — Not RecruitingNot Applicable

Explorative Study to Investigate the Acid-base Response to Sodium and Potassium Salts in Patients With Chronic Kidney Disease.

Netherlands31 participantsStarted 2024-01-26

Plain-language summary

With this research the investigators want to study how patients with chronic kidney disease respond to different sodium- and potassium salts. Potassium salts can prevent kidney damage and cardiovascular disease, however patients with chronic kidney disease can responds differently. Extra potassium can increase the amount of potassium in the blood and extra chloride can cause acidosis. With this study the investigators will gain more insight in how patients with chronic kidney disease respond to sodium and potassium salts and which one is more favorable.This information can then be used to guide the application of salt substitutes and dietary adjustments in patients with chronic kidney disease.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (≥ 18 years) * CKD G3b or G4 (44 - 15 ml/min/1.73 m2) * Use of RAAS-I (ACE-inhibitor or angiotensin receptor blocker, ARB) Exclusion Criteria: * Use of any of the following drugs or supplements: mineralocorticoid receptor antagonists, potassium-sparing diuretics, oral potassium binders, immunosuppressive medication, tolvaptan, acetazolamide, topiramate, sodium bicarbonate. * Patients using double RAAS blockade (i.e., ACE-inhibitor + ARB). * Metabolic alkalosis (plasma bicarbonate \>27 mmol/L) at last outpatient visit * Kidney transplant recipients * Patients with an active gastro-intestinal ulcer * Patients with previous history of ventricular cardiac arrhythmia * Patients with a life expectancy \< 6 months * Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team * Women who are pregnant, breastfeeding or consider pregnancy in the coming 7 weeks * Patients with chronic respiratory acidosis in previous medical history * Hyperkalemia (plasma potassium \>5.5 mmol/L) at V0

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma bicarbonate by blood draw

Timeframe: After 5 days of intervention

Trial details

NCT IDNCT06237712

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-21

View on ClinicalTrials.gov More Metabolic Acidosis trials