Effects of Exogenous Ketosis on Proteinuria and Renal Function
NCT ID: NCT06867471
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
43 participants
INTERVENTIONAL
2024-09-11
2025-12-31
Brief Summary
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Detailed Description
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The use of sodium glucose transporter 2 (SGLT2)-inhibitors, which work by blocking the activity of sodium-glucose-cotransporter 2 channels in the proximal kidney tubule, has completely transformed the treatment of proteinuric kidney disease, with a 28% decrease in the risk for cardiorenal outcomes. Despite these new treatment options, a significant proportion of patients still succumb to kidney failure, require hospitalization for heart failure and die prematurely. Thus, additional preventive measures are essential.
Renewed interest in the physiological role of ketone bodies (KB) has emerged. It has become increasingly clear that ketosis has several beneficial effects including anti-epileptic effects, improved exercise capacity, lipid profile, cardiac function and cognition.
However, only few clinical studies have studied renal effects of exogenous ketosis, and to our knowledge there are no clinical studies examining the effects long term effects of renal ketosis in patients with CKD.
Hypothesis: Ketosis decreases urine albumin to creatinine ratio (ACR) and glomerular filtration rate (GFR) in patients with CKD/PKD.
Methods: A randomized, placebo-controlled, double-blinded crossover study will be conducted. Twenty-nine patients with proteinuric kidney disease (study a) and 14 patients with PKD (study b) 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.
Perspectives: The study has the potential to provide information regarding the therapeutic potential of ketone bodies in patients with CKD/PKD.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Ketone diol (Ketone-IQ), then Placebo drink
For four weeks each subject will receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day, then crossed over to receive a taste and volume matched placebo drink for four weeks.
Each individual will receive 400mg/kg before bedtime in addition to 200mg/kg with a minimum of 6 hours in between throughout the treatment period.
Ketone Diol, R-1,3-butanediol (Ketone-IQ)
Effect variables will be measured on the last day of treatment with Ketone-IQ
Placebo drink
Effect variables will be measured on the last day of treatment with Placebo
Placebo drink, then Ketone diol (Ketone-IQ)
For four weeks each subject will receive a placebo drink twice a day, then crossed over to receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day for four weeks.
Each individual will receive 400mg/kg before bedtime in addition to 200mg/kg with a minimum of 6 hours in between throughout the treatment period.
Ketone Diol, R-1,3-butanediol (Ketone-IQ)
Effect variables will be measured on the last day of treatment with Ketone-IQ
Placebo drink
Effect variables will be measured on the last day of treatment with Placebo
Interventions
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Ketone Diol, R-1,3-butanediol (Ketone-IQ)
Effect variables will be measured on the last day of treatment with Ketone-IQ
Placebo drink
Effect variables will be measured on the last day of treatment with Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gødstrup Hospital
OTHER
Responsible Party
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Principal Investigators
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Trine Z Lyksholm, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital
Locations
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University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
Herning, Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TZL-2-2024
Identifier Type: -
Identifier Source: org_study_id
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