ADPKDPhase 2ADKETONENCT06100133
Treat Autosomal Dominant Polycystic Kidney Disease With Oral Ketone Ester?
A Phase 2 study testing Ketone ester in people with ADPKD, run by Universitair Ziekenhuis Brussel.
Trial summary
The investigators are running a study to see if a special drink, called a "ketone ester", can help people with a type of kidney disease named "Autosomal Dominant Polycystic Kidney Disease" or ADPKD for short. The investigators want to find out: If it's easy for patients to take this drink every day for about 2 months. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- ADPKD
- What is being tested?
- Ketone ester
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jul 2025
- Phase
- Phase 2
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - ADPKD patients (diagnosis based on genetics or imaging) ≥ 16 and ≤ 70 years.
- Total Kidney Volume ≥ 600 mL.
- eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2.
- Normal blood glucose, HbA1C and ketones.
- Women of childbearing potential who are non-lactating and using an effective form of birth control.
- Stable disease-modifying treatment for the last 2 months.
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- Well controlled hypertension (stable antihypertensive medications for at least 2 months).
- BMI > 18 < 30.
- Written informed consent.
Who cannot join
- Exposure to a ketogenic diet or intermittent fasting for more than 2 weeks within 6 months before inclusion.
- Significant weight-loss (> 10%) within 6 months before inclusion.
- Diabetes mellitus.
- Conditions prohibiting the use of a ketogenic diet (liver damage, pancreatic failure, pyruvate-carboxylase deficiency, defects in fatty acid oxidation/gluconeogenesis/ketolysis/neogenesis, hyperinsulinism), based on patient history.
- Diagnosis with any disorder of fatty acid metabolism based on patient history.
- Eating disorder.
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- Alcohol abuse.
- Contraindication for MRI.
- Participation in other interventional trial.
About this study
The investigators are running a study to see if a special drink, called a "ketone ester", can help people with a type of kidney disease named "Autosomal Dominant Polycystic Kidney Disease" or ADPKD for short.
The investigators want to find out:
Read more
If it's easy for patients to take this drink every day for about 2 months. If it's safe and doesn't cause any problems. If it makes a difference in the size and function of the kidneys.
Who can join?
People between 16 to 70 years old who have ADPKD. Those with a certain amount of kidney size and function. People who haven't been on specific diets or lost a lot of weight recently. Women who are not breastfeeding and are using birth control. People with a body weight that is not too low or too high.
Who cannot join?
People who've been on a high-fat diet or skipped meals for a while recently. Those with other health conditions like diabetes or certain metabolic issues. Anyone who has a problem with getting an MRI scan. If participants are in another medical study right now.
The study will happen in two Belgian hospitals and is supported by the UZ Brussel's nephrology department. The investigators hope to include 20 people and start in November 2023.
- Conditions
- ADPKD
- Being tested
- Ketone ester
- Keywords
- ketone ester
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
Also called (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (Ketone Ester)
Up to 100g ketone ester daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Ketone Ester | Experimental | Up to 100g ketone ester daily for 56 days Receives: Dietary Supplement: Ketone ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observance
Objective observance (ketone body levels ≥0.8 mmol/l in ≥75% of blood measurements and ≥60% of maximal theoretic dose determined by used packages and self-report)
Measured: 56 days
Feasibility
Patient reported feasibility, defined as a cohen d effect size of < 0.5 in the ADPKD impact scale.Both targets (observance and self-reported feasibility) must be met to reach the endpoint.
Measured: 56 days
Secondary outcomes (2)
Total Kidney Volume
Change in Total kidney volume (in mL; assessed with MRI) baseline vs day 56
Measured: 56 days
Kidney Function
Change in estimated glomerular filtration rate (eGFR) according to CKD-EPI; baseline vs day 56
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADPKDStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design to register the changes before and after treatment. Non-randomized, non-blinded, multi center prospective interventional cohort trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100133
- Sponsor's protocol ID
- NEFADPKD1
- Acronym
- ADKETONE
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat Autosomal Dominant Polycystic Kidney Disease With Oral Ketone Ester?
- ClinicalTrials.gov ID
- NCT06100133
- Acronym / sponsor ID
- ADKETONE / NEFADPKD1
- Conditions
- ADPKD
- Keywords
- ketone ester
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Oct 2023 (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.
The investigators are running a study to see if a special drink, called a "ketone ester", can help people with a type of kidney disease named "Autosomal Dominant Polycystic Kidney Disease" or ADPKD for short.
The investigators want to find out:
If it's easy for patients to take this drink every day for about 2 months. If it's safe and doesn't cause any problems. If it makes a difference in the size and function of the kidneys.
Who can join?
People between 16 to 70 years old who have ADPKD. Those with a certain amount of kidney size and function. People who haven't been on specific diets or lost a lot of weight recently. Women who are not breastfeeding and are using birth control. People with a body weight that is not too low or too high.
Who cannot join?
People who've been on a high-fat diet or skipped meals for a while recently. Those with other health conditions like diabetes or certain metabolic issues. Anyone who has a problem with getting an MRI scan. If participants are in another medical study right now.
The study will happen in two Belgian hospitals and is supported by the UZ Brussel's nephrology department. The investigators hope to include 20 people and start in November 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design to register the changes before and after treatment. Non-randomized, non-blinded, multi center prospective interventional cohort trial.
| Arm | Type | Receives |
|---|---|---|
| Ketone Ester | Experimental | Dietary Supplement: Ketone esterUp to 100g ketone ester daily for 56 days |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- - ADPKD patients (diagnosis based on genetics or imaging) ≥ 16 and ≤ 70 years.
- Total Kidney Volume ≥ 600 mL.
- eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2.
- Normal blood glucose, HbA1C and ketones.
- Women of childbearing potential who are non-lactating and using an effective form of birth control.
Key exclusion criteria (9 listed)
- Exposure to a ketogenic diet or intermittent fasting for more than 2 weeks within 6 months before inclusion.
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 esterAlso: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (Ketone Ester)Up to 100g ketone ester daily for 56 days | Dietary supplement | Ketone Ester |
Primary outcome
Observance
Time frame: 56 days
Objective observance (ketone body levels ≥0.8 mmol/l in ≥75% of blood measurements and ≥60% of maximal theoretic dose determined by used packages and self-report)
Feasibility
Time frame: 56 days
Patient reported feasibility, defined as a cohen d effect size of < 0.5 in the ADPKD impact scale.Both targets (observance and self-reported feasibility) must be met to reach the endpoint.
2 secondary outcomes
Total Kidney Volume
Time frame: 56 days
Kidney Function
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketone ester in people with ADPKD, run by Universitair Ziekenhuis Brussel.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Observance (time frame: 56 days). 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 25 Oct 2023.