Effects of Ketosis on Kidney Function and Protein Levels
Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease
This study is testing if taking ketone bodies can improve kidney function and protein levels in people with chronic kidney disease and polycystic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning, Jutland) |
| Trial ID | NCT06867471 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of exogenous ketosis on kidney function and protein levels in patients with chronic kidney disease (CKD) and polycystic kidney disease (PKD). It employs a randomized, placebo-controlled, double-blinded crossover design involving 43 participants who will receive either ketone bodies or a placebo over four-week treatment periods, separated by a two-week wash-out phase. The primary outcomes include changes in urine albumin to creatinine ratio and glomerular filtration rate, measured at the end of each treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic kidney disease or polycystic kidney disease who meet specific renal function criteria and are currently on certain medications.
Not a fit: Patients with diabetes, heart failure, liver disease, or those who have undergone kidney transplants are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to slow the progression of kidney disease and improve renal function.
How similar studies have performed: While there is limited research on the renal effects of exogenous ketosis, this approach is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herning, Jutland
- University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital — Herning, Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Trine Z Lyksholm, MD — University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital
- Study coordinator: Trine Z Lyksholm, MD
- Email: trizur@rm.dk
- Phone: 78432534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.