Ren-Nu: a kidney-focused ketogenic diet program for people with polycystic kidney disease
Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease
This 16-week pilot will try a dietitian-led, kidney-safe ketogenic program plus KetoCitra in adults with ADPKD to improve metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07454174 on ClinicalTrials.gov |
What this trial studies
Participants join a 12-week, dietitian-led online program that teaches a plant-focused, kidney-safe ketogenic diet supported by the medical food KetoCitra, with the full pilot spanning 16 weeks. The program includes weekly web-based classes, individualized remote dietitian visits, use of a continuous glucose monitor, and a smartphone app for tracking intake and biomarkers. Laboratory safety monitoring and in-person visits to the Cleveland Clinic are included to tailor recommendations and check safety. Recruitment is rolling and aimed at adults with ADPKD who meet kidney function and other eligibility criteria.
Who should consider this trial
Good fit: Adults with physician-diagnosed ADPKD, eGFR ≥ 30 mL/min/1.73 m2, BMI ≥ 25, controlled blood pressure, and the ability to attend online sessions and use home monitoring devices are ideal candidates.
Not a fit: People with eGFR below 30, a history of hyperkalemia or heart failure, intolerance/allergy to the medical food, or those unable to follow a ketogenic-style diet are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve metabolic markers and support kidney health and quality of life for adults with ADPKD.
How similar studies have performed: This approach is early-stage for ADPKD: small pilot and preclinical work suggest potential metabolic benefits from ketogenic strategies, but large-scale clinical proof is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Adult (18 years or older)
* Diagnosis of ADPKD by a physician.
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
* Appropriate control of blood pressure (i.e. entry reading \<140/90) including the use of BP medications for diagnosis of hypertension.
* BMI ≥ 25 (accounting for muscle mass)
* Own an at-home blood pressure monitor (no brand requirements)
* Able to complete study-related activities (e.g., attend online classes, complete questionnaires, and proper use of medical devices)
Exclusion Criteria:
* Intolerance or allergy to any of the ingredients in the provided medical food
* Severe or rare underlying health conditions may cause a safety risk when taking the medical food. Those underlying health conditions will be assessed by the enrolling physician and include but are not limited to:
* History of hyperkalemia
* Heart failure
* Liver cirrhosis
* Chronic kidney disease stage 4 or greater, or other renal condition that severely impairs bone mineral homeostasis.
* HIV infection
* Chronic drug or alcohol abuse
* Chronic malabsorption syndrome
* Malignancy (non-melanoma skin cancer exempted)
* Autoimmune disease
* Pregnant, planning to be pregnant, or nursing during the course of the study
* Chronic history of recurrent urinary tract infections (UTI) (≥ 3 UTIs per year)
* Diagnosis of aneurysm
* Indigestion due to hypochlorhydria (low stomach acid)
* Any other condition, that in the opinion of the enrolling physician, makes the subject an unsuitable candidate for the study.
* Current use of any of the following medications or supplements which could affect safety or compliance with this study:
* The medical food, KetoCitra®.
* Urine alkalizing agents such as sodium bicarbonate or potassium citrate
* Citrate treatments
* Immunosuppressive treatment
* Tolvaptan
* Potassium-sparing diuretics
* Somatostatin analogs
* Aluminum-containing supplements or medications such as aluminum antacids (e.g. Maalox) or aluminum-based phosphate binders.
* SGLT2 inhibitors
* Participation in another therapeutic intervention trial.
* Following a highly specialized or extreme diet that is incompatible with the interventional nutrition program (e.g. carnivore, very high protein diet for elite athletes, etc.)
* Food sensitivities or allergies that are incompatible with the interventional nutrition program.
* The subject is already adhering to a form of a ketogenic diet or related fasting regimen.
* Current or past history of disordered eating or feeding behaviors.
* History of gastric bypass.
* Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's, or Gallbladder Disease.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Richard Fatica, MD — The Cleveland Clinic
- Study coordinator: Chloe Booth
- Email: boothc2@ccf.org
- Phone: 216-444-5053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.