Renal Insufficiency, ChronicKETO-CKDNCT06867471
Effects of Exogenous Ketosis on Proteinuria and Renal Function
A study testing Ketone Diol, R-1,3-butanediol (Ketone-IQ) in people with Renal Insufficiency, Chronic and Polycystic Kidney Diseases, run by Gødstrup Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Polycystic Kidney Diseases, Proteinuria
- What is being tested?
- Ketone Diol, R-1,3-butanediol (Ketone-IQ)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Sep 2024to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
Herning, Jutland, 7400
About this study
Official title: Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients With Chronic Kidney Disease and Patients With Polycystic Kidney Disease
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.
Read the detailed description
Background: Until recently, the only treatment shown to slow progression of chronic kidney disease (CKD) has been angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).
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.
- Being tested
- Ketone Diol, R-1,3-butanediol (Ketone-IQ), Placebo drink
- Keywords
- Kidney physiology, Glomerular Filtration Rate, Chronic Kidney disease, Ketosis, Proteinuria, Natriuresis
- Medical subject headings
- Renal Insufficiency, Chronic, Polycystic Kidney Diseases, Proteinuria, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Diol, R-1,3-butanediol (Ketone-IQ)Dietary supplement
Effect variables will be measured on the last day of treatment with Ketone-IQ
Placebo drinkOther
Effect variables will be measured on the last day of treatment with Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketone diol (Ketone-IQ), then Placebo drink | Other | 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. Receives: Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ); Other: Placebo drink |
| Placebo drink, then Ketone diol (Ketone-IQ) | Other | 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. Receives: Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ); Other: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Mean difference between Log UACR after 4 weeks treatment with ketone bodies and placebo (primary outcome study a)
Measured: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)
GFR
Mean difference between GFR measured by Technetium99 (Tc99m) - Diethylene Triamine Pentaacetic Acid (DTPA) clearance after 4 weeks treatment with ketone bodies and placebo (primary outcome study b, secondary outcome in study a)
Measured: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Secondary outcomes (9)
Aldosterone
Mean difference in plasma levels of aldosterone (pmol/L) after 4 weeks treatment with ketone bodies and placebo
Measured: Measured on the last day in each treatment period (each treatment period is 4 weeks)
P-Beta-hydroxybutyrate
Change ind p-beta-hydroxybutyrate concentration
Measured: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Excretion rate of renal tubular transport proteins
Mean difference between urine excretion rate of aquaporin 2 (AQP2) (pq/min), thiazide-sensitive sodium-chloride cotransporter (NCC)(pg/min), and distal epithelial sodium channel (ENaC)(pg/min) after 4 weeks treatment with ketone bodies and placebo
Measured: Measured on the last day in each treatment period (each treatment period is 4 weeks)
24-hour Ambulatory Blood Pressure
Mean difference between systolic and diastolic 24-hour ambulatory blood pressure (mmHg) after treatment with ketone bodies and placebo.
Measured: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Sodium and potassium excretion
Diffeence between mean fractional and absolute excretion af sodium and postassium after 4 weeks treatment with ketone bodies and placebo
Measured: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)
Peripherial Vascular Resistance
Mean difference between peripherial vascular resistance (dyn*s/cm5) during treatment with ketone bodies compared to placebo
Measured: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Heart rate
Mean difference between heart rate after 4 weeks treatment with ketone bodies and placebo
Measured: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Pulse Wave Velocity
Mean difference between pulse wave velocity (m/s) after 4 weeks treatment with ketone bodies and placebo
Measured: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Renin
Mean difference in plasma concentration of renin(pmol/L) after 4 weeks treatment with ketone bodies and placebo
Measured: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start11 Sep 2024
- Primary completion10 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Z Lyksholm, MD, Principal investigator, University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867471
- Sponsor's protocol ID
- TZL-2-2024
- Acronym
- KETO-CKD
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients With Chronic Kidney Disease and Patients With Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06867471
- Acronym / sponsor ID
- KETO-CKD / TZL-2-2024
- Keywords
- Kidney physiology, Glomerular Filtration Rate, Chronic Kidney disease, Ketosis, Proteinuria, Natriuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Until recently, the only treatment shown to slow progression of chronic kidney disease (CKD) has been angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone diol (Ketone-IQ), then Placebo drink | Other | Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ), Other: Placebo drinkFor 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. |
| Placebo drink, then Ketone diol (Ketone-IQ) | Other | Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ), Other: Placebo drinkFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Prior diagnose with PKD
Key exclusion criteria (11 listed)
- Diabetes Mellitus type 1
- Heart Failure
- Liver Disease
- Kidney transplant
- Malignant diseases (except skin cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Diol, R-1,3-butanediol (Ketone-IQ)Effect variables will be measured on the last day of treatment with Ketone-IQ | Dietary supplement | Ketone diol (Ketone-IQ), then Placebo drink, Placebo drink, then Ketone diol (Ketone-IQ) |
| Placebo drinkEffect variables will be measured on the last day of treatment with Placebo | Other | Ketone diol (Ketone-IQ), then Placebo drink, Placebo drink, then Ketone diol (Ketone-IQ) |
Primary outcome
Proteinuria
Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)
Mean difference between Log UACR after 4 weeks treatment with ketone bodies and placebo (primary outcome study a)
GFR
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Mean difference between GFR measured by Technetium99 (Tc99m) - Diethylene Triamine Pentaacetic Acid (DTPA) clearance after 4 weeks treatment with ketone bodies and placebo (primary outcome study b, secondary outcome in study a)
9 secondary outcomes
Aldosterone
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
P-Beta-hydroxybutyrate
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Excretion rate of renal tubular transport proteins
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
24-hour Ambulatory Blood Pressure
Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Sodium and potassium excretion
Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)
Peripherial Vascular Resistance
Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Heart rate
Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Pulse Wave Velocity
Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)
Renin
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Z Lyksholm, MD principal investigator
University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Diol, R-1,3-butanediol (Ketone-IQ) in people with Renal Insufficiency, Chronic and Polycystic Kidney Diseases, run by Gødstrup Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteinuria (time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.