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Tests a ketogenic diet in adults with polycystic kidney disease at high risk

Tests a low-carbohydrate diet in adults with polycystic kidney disease.

Plain-language title generated from the registry record
Registry title: Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Key facts

Where
Columbus, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT06325644, who can take part

Where in United States

  • The Ohio State UniversityColumbus, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Ohio State University
Trial code
NCT06325644
Record updated
3 November 2026
Original description
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.Read full original descriptionShow less

Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression

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.

Inclusion: 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.

Exclusion: Patients currently being treated with Tolvaptan; Chronic alcohol or drug abuse; Diagnosed with diabetes; Gastrointestinal disorders that will interfere with diet intervention; Severe kidney disease with GFR < 25 mg/dl; Pregnancy; Contraindications to MRI; Ketogenic diet within the last three months; Unable to purchase food for the diet intervention.

ClinicalTrials.gov NCT06325644