NCT07454174 Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease
| NCT ID | NCT07454174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Richard Fatica |
| Condition | Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-02-25 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Richard Fatica, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07454174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autosomal Dominant Polycystic Kidney Disease (ADPKD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454174 currently recruiting?
Yes, NCT07454174 is actively recruiting participants. Contact the research team at boothc2@ccf.org for enrollment information.
Where is the NCT07454174 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07454174 clinical trial?
NCT07454174 is sponsored by Richard Fatica. The principal investigator is Richard Fatica, MD at The Cleveland Clinic. The trial plans to enroll 20 participants.
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