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Recruiting NCT06867471

Effects of Exogenous Ketosis on Proteinuria and Renal Function

Trial Parameters

Condition Renal Insufficiency, Chronic
Sponsor Gødstrup Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 43
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-11
Completion 2025-12
Interventions
Ketone Diol, R-1,3-butanediol (Ketone-IQ)Placebo drink

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

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