Effect of a Ketogenic Diet on Polycystic Kidney Disease
Official title: Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
Run by Ohio State University · NCT06325644 · Data updated 2026-11-12
This study is testing if following a ketogenic diet for a year can help people with polycystic kidney disease keep their kidneys healthier and slow down the disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | April 1, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT06325644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with a diagnosis of ADPKD and specific risk factors for rapid disease progression.
✕Probably not a fit
Patients currently treated with Tolvaptan, those with diabetes, or severe kidney disease (GFR < 25 mg/dl) may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of a ketogenic diet on patients with autosomal dominant polycystic kidney disease (ADPKD) who are at high risk for progression to end-stage renal disease (ESRD). It is a prospective, single-center study involving 20 participants who will undergo MRI and various blood and urinary tests at baseline, 6 months, and 52 weeks. The ketogenic diet will be followed for a year, with monitoring of ketone and glucose levels, and the investigatory diet team will provide support throughout the intervention. The goal is to assess changes in kidney volume, glomerular filtration rate (GFR), and microalbuminuria.
Why it matters
Potential benefit: If successful, this approach could provide a dietary intervention that slows the progression of kidney disease in patients with ADPKD.
How similar studies have gone: While dietary interventions in kidney disease are being explored, this specific approach using a ketogenic diet in ADPKD is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients currently being treated with Tolvaptan * Diagnosed with diabetes. * Pregnancy * Contraindications to MRI * Ketogenic diet within the last three months * Severe kidney disease with GFR \< 25 mg/dl * Unable to purchase food for the diet intervention * Gastrointestinal disorders that will interfere with diet intervention * Chronic alcohol or drug abuse
Where it's running
-
The Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Study coordinator: Madison L Kackley, PhD
- Email: kackley.19@osu.edu
- Phone: 6142479650
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Amnioinfusion to help fetuses with kidney problems
This study is testing if giving extra fluid to pregnant women with fetuses that have serious kidney problems can help improve the babies' chances of survival and healthy development.
-
Observational study on early-stage polycystic kidney disease
This study is collecting samples from people with early-stage polycystic kidney disease and their family members to find signs that show how the disease is changing, which could help create new treatments.
-
Observational study on Polycystic Kidney Disease
This study is trying to learn more about autosomal dominant polycystic kidney disease by gathering information from 350 adults to improve understanding of the disease and its effects on health.
-
Data collection for understanding Polycystic Kidney Disease
This study is collecting detailed health information from people with autosomal dominant polycystic kidney disease to better understand the condition and improve treatment options.
-
Managing Depressive Symptoms in ADPKD: testing Digital Neurotherapy and Capacity Coaching
This study tests whether Digital Neurotherapy or Capacity Coaching can help people with ADPKD who have depression and self-reported pain, compared to education alone.
-
AZD1613 safety and how the body handles it in adults with ADPKD
We will test whether AZD1613 given under the skin or into a vein is safe and how the body processes it in adults with ADPKD who have eGFR between 45 and 90 mL/min/1.73m2.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.