Ren-Nu: a kidney-focused ketogenic diet program for people with polycystic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VX-407 pharmacokinetics after a single dose in adults with ADPKD

  This study tests how VX-407 is absorbed, distributed, metabolized, and excreted after a one-time oral dose in adults with polycystic kidney disease.

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• How VX-407 interacts with common birth control pills

  This study tests whether VX-407 affects how birth control pills work in people with ADPKD.

  Recruiting Phase 1 Vertex Pharmaceuticals Incorporated · Montreal · NCT07792408

• Renal embolization with EVOH for adults on dialysis with ADPKD

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  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07535385

• High blood pressure in children and teenagers at risk of ADPKD

  This project will use MRI, blood tests, arterial stiffness measures, and ambulatory blood pressure monitoring to see how common high blood pressure is in 12–17-year-olds who have a parent with ADPKD.

  Recruiting King's College London · London · NCT07260071

• Evaluating the safety of PYC-003 for treating a kidney disease

  This study is testing a new drug called PYC-003 to see if it's safe for people with a specific type of kidney disease and healthy adults.

  Recruiting at 12 sites Phase 1 PYC Therapeutics · Southport, Gold Coast and 11 other locations · NCT06714006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.