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New treatment option for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official title Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT07454174
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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)
You likely can't join if
- 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...
- History of hyperkalemia
- Heart failure
- Liver cirrhosis
- Chronic kidney disease stage 4 or greater, or other renal condition that severely impairs bone mineral homeostasis.
See the full eligibility 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)
- 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 treatment nutrition program (e.g. carnivore, very high protein diet for elite athletes, etc.)
- Food sensitivities or allergies that are incompatible with the treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.