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Effects of Exogenous Ketosis on Proteinuria and Renal Function

ConditionsRenal Insufficiency, ChronicPolycystic Kidney DiseasesProteinuriaKetosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGødstrup Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diabetes Mellitus type 1

Heart Failure

Liver Disease

Kidney transplant

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

43 Participants
are divided into 2 treatment groups
Group A: Ketone diol (Ketone-IQ), then Placebo drinkOther 2 interventions
Group B: Placebo drink, then Ketone diol (Ketone-IQ)Other 2 interventions

Trial outcomes

Primary outcomes

1

Proteinuria

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

Time frame
Measured on 24 hour urine collection on the last day in each treatment period (each treatment period is 4 weeks)
2

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)

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

Secondary outcomes

1

Aldosterone

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

Time frame
Measured on the last day in each treatment period (each treatment period is 4 weeks)
2

P-Beta-hydroxybutyrate

Change ind p-beta-hydroxybutyrate concentration

Time frame
Measured on the last day in each treatment period (each treatment period is 4 weeks)
3

Excretion rate of renal tubular transport proteins

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

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

24-hour Ambulatory Blood Pressure

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gødstrup Hospital

Lead sponsor

Source ClinicalTrials.gov
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