An interventional study of Ketone Diol, R-1,3-butanediol (Ketone-IQ) and Placebo drink in Renal Insufficiency, Chronic, Polycystic Kidney Diseases and Proteinuria, sponsored by Gødstrup Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Gødstrup Hospital · Not applicable, Interventional, and Prevention
Among 116 studies in Renal Insufficiency, Chronic with a site in Denmark — 27 open to participants now, 35 under way, 9 of them phase 3. Renal Insufficiency, Chronic · Denmark.
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, this one is the 70th largest by enrollment of the 90 interventional ones, is one of 14 that started in 2024, is one of 27 with no phase, and was the 98th registered.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 45 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →27 of the 116 studies in Renal Insufficiency, Chronic with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →116 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 14 started in 2024.
Median enrollment 136 across the 90 interventional studies, 321 across the 26 observational. Of the 73 that completed or were terminated, 28 (38%) have results posted.
52 of 116 have an industry lead sponsor. The 10 most frequent:
Gødstrup Hospital is the lead sponsor of 24 studies on the registry; 14 are open to participants now.
Gødstrup Hospital has 2 studies filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
9 of the studies in Renal Insufficiency, Chronic with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT07781371Novo Nordisk A/SA Retrospective Real-World Cohort Study | 2026-11-02 |
| NCT07026539University of AarhusEffect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes. | 2026-12-31 |
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study A (patients with CKD):
Study B (patients with PKD):
Exclusion Criteria (Study A+B)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ) · Other: Placebo drink
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.
Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ) · Other: Placebo drink
Effect variables will be measured on the last day of treatment with Ketone-IQ
Effect variables will be measured on the last day of treatment with Placebo
Proteinuria
Mean difference between Log UACR after 4 weeks treatment with ketone bodies and placebo (primary outcome study a)
Time frame: 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)
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Aldosterone
Mean difference in plasma levels of aldosterone (pmol/L) after 4 weeks treatment with ketone bodies and placebo
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
P-Beta-hydroxybutyrate
Change ind p-beta-hydroxybutyrate concentration
Time frame: 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
Time frame: 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.
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
Diffeence between mean fractional and absolute excretion af sodium and postassium after 4 weeks treatment with ketone bodies and placebo
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
Mean difference between peripherial vascular resistance (dyn\*s/cm5) during treatment with ketone bodies compared to placebo
Time frame: 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
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
Mean difference between pulse wave velocity (m/s) after 4 weeks treatment with ketone bodies and placebo
Time frame: 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
Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Dec 2025, 14 months.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 14 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: R-1,3-Butanediol-based Supplement
Renal Insufficiency, Chronic →
Gødstrup Hospital