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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
RECRUITING
Herning
Contact Information
Primary
Trine Z Lyksholm, MD
trizur@rm.dk
78432534
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 43
Treatments
Other: Ketone diol (Ketone-IQ), then Placebo drink
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.
Other: Placebo drink, then Ketone diol (Ketone-IQ)
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.
Related Therapeutic Areas
Polycystic Kidney Disease
Sponsors
Leads: Gødstrup Hospital

This content was sourced from clinicaltrials.gov

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