Study on Effects of Ketone-IQ on Kidney Function and Protein in Urine in Adults with Chronic Kidney Disease or Polycystic Kidney Disease

What this Trial Is About

Researchers are evaluating the effects of exogenous ketosis on proteinuria and kidney function in patients with chronic kidney disease CKD and polycystic kidney disease PKD. This randomized, placebo-controlled, double-blinded crossover study aims to explore if ketone bodies Ketone-IQ can reduce urine albumin to creatinine ratio ACR and glomerular filtration rate GFR, addressing the need for additional treatments beyond current options like ACE inhibitors, ARBs, and SGLT2 inhibitors. The study involves patients with proteinuric kidney disease and PKD, focusing on the therapeutic potential of ketosis in these populations. Participants will receive ketone bodies Ketone-IQ and a placebo drink in a randomized order, each for four weeks, separated by a two-week wash-out period. Ketone-IQ is given twice daily as a drink containing Ketone Diol, R-1,3-butanediol, dosed at 400 mgkg before bedtime and 200 mgkg at least six hours earlier. The placebo drink is matched in taste and volume. The crossover design allows each participant to serve as their own control, enhancing the studys evaluation of ketone bodies impact on kidney function. During the study, measurements will be taken on the last day of each treatment period, including 24-hour urine protein levels proteinuria, GFR, aldosterone, Beta-hydroxybutyrate, renal tubular transport proteins, ambulatory blood pressure, sodium and potassium excretion, peripheral vascular resistance, heart rate, pulse wave velocity, and renin levels. The study includes safety monitoring and aims to provide comprehensive data on how exogenous ketosis affects kidney health over the treatment periods. Participants are involved for approximately ten weeks including treatment and wash-out phases.

Effects of Exogenous Ketosis on Proteinuria and Renal Function