Effects of Exogenous Ketosis on Proteinuria and Renal Function

NCT06867471 | Recruiting

• 1 other identifier: TZL-2-2024
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Proteinuria; Ketosis

Keywords

Kidney physiology; Glomerular Filtration Rate; Chronic Kidney disease; Ketosis; Proteinuria; Natriuresis

Outcome Measures

Primary Outcomes (2)

• Proteinuria

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

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

• GFR

  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)

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

Secondary Outcomes (9)

• Aldosterone

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

• P-Beta-hydroxybutyrate

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

• Excretion rate of renal tubular transport proteins

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

• 24-hour Ambulatory Blood Pressure

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

• Sodium and potassium excretion

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

Study Arms (2)

Ketone diol (Ketone-IQ), then Placebo drink

OTHER

For four weeks each subject will receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day, then crossed over to receive a taste and volume matched placebo drink for four weeks. Each individual will receive 400mg/kg before bedtime in addition to 200mg/kg with a minimum of 6 hours in between throughout the treatment period.

Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ); Other: Placebo drink

Placebo drink, then Ketone diol (Ketone-IQ)

OTHER

For four weeks each subject will receive a placebo drink twice a day, then crossed over to receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day for four weeks. Each individual will receive 400mg/kg before bedtime in addition to 200mg/kg with a minimum of 6 hours in between throughout the treatment period.

Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ); Other: Placebo drink

Interventions

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

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

Ketone diol (Ketone-IQ), then Placebo drink; Placebo drink, then Ketone diol (Ketone-IQ)

Placebo drink OTHER

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

Ketone diol (Ketone-IQ), then Placebo drink; Placebo drink, then Ketone diol (Ketone-IQ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study A (patients with CKD):
• ACR \> 200 mg/g \<3000 mg/g
• eGFR \>30 ml/min/1,73m2
• Safe contraception if women in childbearing age
• Study B (patients with PKD):
• Prior diagnose with PKD
• eGFR \>30 ml/min/1,73m2
• Safe contraception if women in childbearing age

You may not qualify if:

• Diabetes Mellitus type 1
• Heart Failure
• Liver Disease
• Kidney transplant
• Malignant diseases (except skin cancer)
• Pregnancy or breast feeding
• Alcohol or drug abuse
• Treatment with nitrate

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital

Herning, Jutland, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Proteinuria; Ketosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Trine Z Lyksholm, MD

  University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trine Z Lyksholm, MD

CONTACT

78432534; trizur@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ketone-IQ and the placebo drink will be transferred to neutral bottles and relabeled. The local pharmacy will be handling the blinding and randomization.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: March 10, 2025
• Study Start: September 11, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)