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NCT Number: NCT06867471

Effects of Exogenous Ketosis on Proteinuria and Renal Function

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.

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Key information

Conditions

Renal Insufficiency, Chronic Abnormalities, Multiple Acid-Base Imbalance Acidosis Chronic Disease Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Ketosis Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polycystic Kidney Diseases Proteinuria Renal Insufficiency Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital

Herning, Jutland, 7400, Denmark

Location status: Recruiting

Location contact

Trine Z Lyksholm, MD

CONTACT

[email protected]

+4578432534

About this study

Background: Until recently, the only treatment shown to slow progression of chronic kidney disease (CKD) has been angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs).

The use of sodium glucose transporter 2 (SGLT2)-inhibitors, which work by blocking the activity of sodium-glucose-cotransporter 2 channels in the proximal kidney tubule, has completely transformed the treatment of proteinuric kidney disease, with a 28% decrease in the risk for cardiorenal outcomes. Despite these new treatment options, a significant proportion of patients still succumb to kidney failure, require hospitalization for heart failure and die prematurely. Thus, additional preventive measures are essential.

Renewed interest in the physiological role of ketone bodies (KB) has emerged. It has become increasingly clear that ketosis has several beneficial effects including anti-epileptic effects, improved exercise capacity, lipid profile, cardiac function and cognition.

However, only few clinical studies have studied renal effects of exogenous ketosis, and to our knowledge there are no clinical studies examining the effects long term effects of renal ketosis in patients with CKD.

Hypothesis: Ketosis decreases urine albumin to creatinine ratio (ACR) and glomerular filtration rate (GFR) in patients with CKD/PKD.

Methods: A randomized, placebo-controlled, double-blinded crossover study will be conducted. Twenty-nine patients with proteinuric kidney disease (study a) and 14 patients with PKD (study b) 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.

Perspectives: The study has the potential to provide information regarding the therapeutic potential of ketone bodies in patients with CKD/PKD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketone Diol, R-1,3-butanediol (Ketone-IQ)

Dietary Supplement

Effect variables will be measured on the last day of treatment with Ketone-IQ

Placebo drink

Other

Effect variables will be measured on the last day of treatment with Placebo

Primary outcomes

  1. Proteinuria

    Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between Log UACR after 4 weeks treatment with ketone bodies and placebo (primary outcome study a)

  2. GFR

    Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between GFR measured by Technetium99 (Tc99m) - Diethylene Triamine Pentaacetic Acid (DTPA) clearance after 4 weeks treatment with ketone bodies and placebo (primary outcome study b, secondary outcome in study a)

Secondary outcomes

  1. Aldosterone

    Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference in plasma levels of aldosterone (pmol/L) after 4 weeks treatment with ketone bodies and placebo

  2. P-Beta-hydroxybutyrate

    Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)

    Change ind p-beta-hydroxybutyrate concentration

  3. Excretion rate of renal tubular transport proteins

    Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between urine excretion rate of aquaporin 2 (AQP2) (pq/min), thiazide-sensitive sodium-chloride cotransporter (NCC)(pg/min), and distal epithelial sodium channel (ENaC)(pg/min) after 4 weeks treatment with ketone bodies and placebo

  4. 24-hour Ambulatory Blood Pressure

    Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between systolic and diastolic 24-hour ambulatory blood pressure (mmHg) after treatment with ketone bodies and placebo.

  5. Sodium and potassium excretion

    Time frame: Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)

    Diffeence between mean fractional and absolute excretion af sodium and postassium after 4 weeks treatment with ketone bodies and placebo

  6. Peripherial Vascular Resistance

    Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between peripherial vascular resistance (dyn*s/cm5) during treatment with ketone bodies compared to placebo

  7. Heart rate

    Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between heart rate after 4 weeks treatment with ketone bodies and placebo

  8. Pulse Wave Velocity

    Time frame: Measured using a Mobil-o-graph on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference between pulse wave velocity (m/s) after 4 weeks treatment with ketone bodies and placebo

  9. Renin

    Time frame: Measured on the last day in each treatment period (each treatment period is 4 weeks)

    Mean difference in plasma concentration of renin(pmol/L) after 4 weeks treatment with ketone bodies and placebo

Study contacts

Contact information is provided by the study sponsor or research team.

Trine Z Lyksholm, MD

CONTACT

[email protected]

78432534 ext. 0045

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Registry information

Official study title

Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease

Acronym: KETO-CKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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