Effects of Exogenous Ketosis on Proteinuria and Renal Function

Launched by GØDSTRUP HOSPITAL · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a special supplement called Ketone-IQ on kidney health in patients with certain types of kidney disease. The study involves 43 participants: 14 with polycystic kidney disease (PKD) and 29 with proteinuric kidney disease, which means they have protein in their urine. Participants will receive either Ketone-IQ or a placebo (a non-active substance) in a random order for four weeks at a time, with a two-week break in between. The researchers want to see if taking Ketone-IQ can help improve kidney function and reduce protein levels in the urine.

To be eligible for the trial, participants should be between 65 and 74 years old, have certain kidney health measurements, and have been on specific medications for at least four weeks before joining. Importantly, individuals with diabetes, heart or liver diseases, or those who have had recent serious health issues are not eligible. Throughout the study, participants will be closely monitored, and they can expect to have their kidney function and protein levels checked at the end of each treatment period. This trial is currently recruiting participants who meet the criteria, and it offers an opportunity to explore a new approach for managing kidney disease.

Gender

ALL

Eligibility criteria

• • 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