RecruitingNot Applicable

Effects of Exogenous Ketosis on Proteinuria and Renal Function

Denmark43 participantsStarted 2024-09-11

Plain-language summary

A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.

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 Study A (patients with CKD): * ACR \> 200 mg/g \<3000 mg/g * eGFR \>30 ml/min/1,73m2 * Treatment with Renin-Angiotension System (RAS) blockers and SGLT-2 inhibitors for a minimum of 4 weeks prior to inclusion * Safe contraception if women in childbearing age Study B (patients with PKD): * Prior diagnose with PKD * eGFR \>30 ml/min/1,73m2 * Treatment with Renin-Angiotension System (RAS) blockers for a minimum of 4 weeks prior to inclusion * Safe contraception if women in childbearing age Exclusion Criteria (Study A+B) * Diabetes Mellitus type 1 * Heart Failure * Liver Disease * Kidney transplant * Malignant diseases (except skin cancer) * Recent acute myocardial infarction (AMI), apoplexia/transient ischemic attack (TIA) (within 3 months of inclusion) * Pregnancy or breast feeding * Alcohol or drug abuse * Periodic fasting within four weeks of inclusion * Routinely intake of ketogenic diet within four weeks of inclusion * Treatment with nitrate

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

Proteinuria

Timeframe: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)

GFR

Timeframe: Measured on the last day in each treatment period (each treatment period is 4 weeks)

Trial details

NCT IDNCT06867471

SponsorGødstrup Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Trine Z Lyksholm, MD

78432534 trizur@rm.dk

View on ClinicalTrials.gov More Renal Insufficiency, Chronic trials