Effects of Exogenous Ketosis on Proteinuria and Renal Function
Recruiting · NCT06867471 · Interventional (participants receive a specific treatment) · Lead sponsor: Gødstrup Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Ketone Diol, R-1,3-butanediol (Ketone-IQ)Placebo drink
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital - Herning, Jutland, Denmark