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Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Polycystic Kidney Disease
Led by Gødstrup Hospital · Updated on 2025-03-10
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of exogenous ketosis on proteinuria and kidney function in patients with chronic kidney disease (CKD) and polycystic kidney disease (PKD). This randomized, placebo-controlled, double-blinded crossover study aims to explore if ketone bodies (Ketone-IQ) can reduce urine albumin to creatinine ratio (ACR) and glomerular filtration rate (GFR), addressing the need for additional treatments beyond current options like ACE inhibitors, ARBs, and SGLT2 inhibitors. The study involves patients with proteinuric kidney disease and PKD, focusing on the therapeutic potential of ketosis in these populations. Participants will receive ketone bodies (Ketone-IQ) and a placebo drink in a randomized order, each for four weeks, separated by a two-week wash-out period. Ketone-IQ is given twice daily as a drink containing Ketone Diol, R-1,3-butanediol, dosed at 400 mg/kg before bedtime and 200 mg/kg at least six hours earlier. The placebo drink is matched in taste and volume. The crossover design allows each participant to serve as their own control, enhancing the study's evaluation of ketone bodies' impact on kidney function. During the study, measurements will be taken on the last day of each treatment period, including 24-hour urine protein levels (proteinuria), GFR, aldosterone, Beta-hydroxybutyrate, renal tubular transport proteins, ambulatory blood pressure, sodium and potassium excretion, peripheral vascular resistance, heart rate, pulse wave velocity, and renin levels. The study includes safety monitoring and aims to provide comprehensive data on how exogenous ketosis affects kidney health over the treatment periods. Participants are involved for approximately ten weeks including treatment and wash-out phases.
CONDITIONS
Brief Title
Effects of Exogenous Ketosis on Proteinuria and Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- For proteinuric kidney disease: urine albumin to creatinine ratio (ACR) between 200 mg/g and 3000 mg/g
- For all participants: estimated glomerular filtration rate (eGFR) greater than 30 ml/min/1.73m2
- Treatment with Renin-Angiotensin System (RAS) blockers for at least 4 weeks prior to inclusion
- For proteinuric kidney disease patients: treatment with SGLT-2 inhibitors for at least 4 weeks prior to inclusion
- Safe contraception use for women of childbearing age
- Prior diagnosis of polycystic kidney disease (for PKD group)
You will not qualify if you...
- Type 1 diabetes mellitus
- Heart failure
- Liver disease
- Kidney transplant
- Malignant diseases except skin cancer
- Recent acute myocardial infarction or stroke within 3 months before inclusion
- Pregnancy or breastfeeding
- Alcohol or drug abuse
- Periodic fasting within 4 weeks before inclusion
- Routine ketogenic diet intake within 4 weeks before inclusion
- Treatment with nitrate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks per treatment period with a 2-week washout in between
Participants receive two different drinks in a randomized order: Ketone-IQ and a placebo drink. Each drink is taken twice a day for four weeks with a two-week washout period between treatments.
Visits on the last day of each 4-week treatment period for assessments
Trial Site Locations
Total: 1 location
1
University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
Herning, Jutland, Denmark, 7400
Actively Recruiting
Research Team
T
Trine Z Lyksholm, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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