Treat Autosomal Dominant Polycystic Kidney Disease With O... | NCT06100133

Studies
Treat Autosomal Dominant Polycystic Kidney Disease With Oral Ketone Ester?

NCT06100133

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Oct 25, 2023Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

ADPKD

Interventions

Ketone ester

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Sep 29, 2023

First Submission Date that Met QC Criteria

Oct 20, 2023

First Posted Date

Oct 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2023

Last Update Posted Date

Oct 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketone Ester	Experimental	Up to 100g ketone ester daily for 56 days	Dietary Supplement: Ketone ester

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketone ester	Dietary Supplement	Up to 100g ketone ester daily for 56 days	Ketone Ester

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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.	56 days

Secondary Outcomes

Measure	Description	Time Frame
Total Kidney Volume	Change in Total kidney volume (in mL; assessed with MRI) baseline vs day 56	56 days
Kidney Function	Change in estimated glomerular filtration rate (eGFR) according to CKD-EPI; baseline vs day 56

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 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.
Well controlled hypertension (stable antihypertensive medications for at least 2 months).
BMI > 18 < 30.
Written informed consent.

Exclusion Criteria:

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.
- Alcohol abuse.
- Contraindication for MRI.
- Participation in other interventional trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016891	Polycystic Kidney, Autosomal Dominant

Ancestor Terms

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided