Actively Recruiting
Effects of Exogenous Ketosis on Proteinuria and Renal Function
Led by Gødstrup Hospital · Updated on 2025-03-10
43
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effects of Exogenous Ketosis on Proteinuria and Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For patients with proteinuric chronic kidney disease (Study A): urine albumin to creatinine ratio (ACR) greater than 200 mg/g and less than 3000 mg/g
- For Study A: estimated glomerular filtration rate (eGFR) greater than 30 ml/min/1.73m2
- For Study A: treatment with Renin-Angiotensin System (RAS) blockers and SGLT-2 inhibitors for at least 4 weeks before joining the study
- For patients with polycystic kidney disease (Study B): prior diagnosis of PKD
- For Study B: eGFR greater than 30 ml/min/1.73m2
- For Study B: treatment with Renin-Angiotensin System (RAS) blockers for at least 4 weeks before joining the study
- Women of childbearing age must use safe contraception
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Heart failure
- Liver disease
- History of kidney transplant
- Malignant diseases, except skin cancer
- Recent acute myocardial infarction (heart attack) or stroke/transient ischemic attack within 3 months before joining
- Pregnancy or breastfeeding
- Alcohol or drug abuse
- Periodic fasting within 4 weeks before joining
- Regular ketogenic diet use within 4 weeks before joining
- Treatment with nitrate medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
Herning, Jutland, Denmark, 7400
Actively Recruiting
Research Team
T
Trine Z Lyksholm, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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