NCT06867471 Effects of Exogenous Ketosis on Proteinuria and Renal Function
| NCT ID | NCT06867471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gødstrup Hospital |
| Condition | Renal Insufficiency, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 43 participants in total. It began in 2024-09-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria 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): * 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 (Study A+B) * 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) * 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
Contact & Investigator
Trine Z Lyksholm, MD
PRINCIPAL INVESTIGATOR
University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital
Frequently Asked Questions
Who can join the NCT06867471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Insufficiency, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867471 currently recruiting?
Yes, NCT06867471 is actively recruiting participants. Contact the research team at trizur@rm.dk for enrollment information.
Where is the NCT06867471 trial being conducted?
This trial is being conducted at Herning, Denmark.
Who is sponsoring the NCT06867471 clinical trial?
NCT06867471 is sponsored by Gødstrup Hospital. The principal investigator is Trine Z Lyksholm, MD at University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital. The trial plans to enroll 43 participants.