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NCT07454174Recruiting

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

This is a 16 week pilot study of the impact of a nutritionist led ketogenic diet (Ren-Nu) supplemented with the medical food KetoCitra on autosomal dominant polycystic kidney disease.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
27 Jan 2026
Start date
25 Feb 2026
Primary completion date
Feb 2027
Lead sponsor
Richard Fatica
NCT number
NCT07454174

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 25 Feb 2026 to the primary completion date, Feb 2027
  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.