Recruiting

Ren-Nu with KetoCitra

Sponsor:

Richard Fatica

Code:

NCT07454174

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ren-Nu and KetoCitra

Study Details

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study ID

NCT07454174

Start date

Feb 25, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD

Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement

Interventions

Ren-Nu and KetoCitra

This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters

Primary outcome measure

  • Change in Serum Renal Function [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Serum Hepatic Function Biomarkers [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Glycemic Control [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Systemic Inflammation Markers [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Serum Measures of Lipids [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in 24-Hour Urine Collection to track Lithogenic Risk [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Glycemic Variability via a Continuous Glucose Monitor (CGM) [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Anthropometric Measures [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Blood Pressure [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]
  • Change in Serum Fatty Acid [ Time Frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu ]

Central Contacts and Locations

Central contacts

Chloe Booth

216-444-5053boothc2@ccf.org

Richard Fatica, MD

216-445-9953faticar@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Chloe Booth

216-444-5053boothc2@ccf.org

Richard Fatica, MD

216-445-9953faticar@ccf.org

Principal Investigator:

Richard Fatica, MD

More Information

Sponsor

Richard Fatica

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • ADPKD
  • polycystic kidneys
  • Ren-Nu
  • KetoCitra
  • Keto diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Richard Fatica on 2026-03-06.