NCT06325644Recruiting
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Ohio State University
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06325644
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Jun 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently being treated with Tolvaptan
- Chronic alcohol or drug abuse
Other illness
- Diagnosed with diabetes.
- Gastrointestinal disorders that will interfere with diet intervention
Lab values
- Severe kidney disease with GFR \< 25 mg/dl
Other
- Pregnancy
- Contraindications to MRI
- Ketogenic diet within the last three months
- Unable to purchase food for the diet intervention
Who the study is looking for
- Age 18-65 years old
- Diagnosis of ADPKD by imaging and/or genetic testing
- GFR ≥ 25 mg/dl
- Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
- No changes of medications within the last three months.
- Able to comply with dietary intervention
- Ability to sign informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.