Effects of Exogenous Ketosis on Proteinuria and Renal Function
Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease
Gødstrup Hospital
43 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 Criteria11
- 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
Interventions
Effect variables will be measured on the last day of treatment with Ketone-IQ
Effect variables will be measured on the last day of treatment with Placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06867471