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New treatment option for Renal Insufficiency, Chronic
Official title Effects of Exogenous Ketosis on Proteinuria and Renal Function
ClinicalTrials.gov ID: NCT06867471
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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):
You likely can't join if
- (Study A+B)
- Diabetes Mellitus type 1
- Heart Failure
- Liver Disease
- Kidney transplant
- Malignant diseases (except skin cancer)
See the full eligibility 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
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Herning, Jutland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herning, Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.