Autosomal Dominant Polycystic Kidney Disease (ADPKD)PKD-KETONCT07454174
Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease
A study testing Ren-Nu and KetoCitra in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Richard Fatica at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- Ren-Nu and KetoCitra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Chloe Booth, 216-444-5053, boothc2@ccf.org
Richard Fatica, MD, 216-445-9953, faticar@ccf.org
About this study
Official title: Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease
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.
Read the detailed description
The goal of the Ren-Nu program aims to improve the metabolic health of ADPKD patients by implementing a plant-focused, kidney-safe, ketogenic diet supported by medical food KetoCitra®. It is a dietitian-led, online group program focused on ketogenic metabolic therapy with rolling recruitment .
For 12 weeks, participants will be remotely directed through the Ren-Nu program by an experienced renal dietitian where they will learn to implement diet and lifestyle changes by completing weekly web-based classes on nutrition principles and food preparation. A continuous glucose monitor (CGM) will be provided for use during the study. Additionally, they will use a smartphone application to track nutrient intake, self-monitor biomarkers, implement mindfulness practice, and participate in facilitated discussions to build community support. Each participant will meet remotely with the renal dietitian and complete laboratory safety monitoring throughout the program to tailor dietary recommendations for optimal compliance. The study will involve visits to the research institution, histories, physical examinations and laboratory work.
- Being tested
- Ren-Nu and KetoCitra
- Keywords
- ADPKD, polycystic kidneys, Ren-Nu, KetoCitra, Keto diet
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ren-Nu and KetoCitraDietary supplement
Also called Continuous glucose monitoring, intermittent fasting, Nutritional counseling
This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters
| Study group | Role | What they receive |
|---|---|---|
| Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD | Experimental | Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement Receives: Dietary Supplement: Ren-Nu and KetoCitra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Renal Function
Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Serum Hepatic Function Biomarkers
Change from baseline of serum liver panel biomarkers to track safety signals. Biomarkers include: AST (U/L), ALT (U/L), and LDH (U/L). Measured via standard clinical laboratory assays.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Glycemic Control
Change from baseline of glycemic control as measured by aggregate of Hgb A1c and Homeostatic model assessment of insulin resistance (HOMA-IR).
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Systemic Inflammation Markers
Change from baseline of inflammatory biomarkers as an aggregate using: serum C-reactive protein [(CRP) mg/dL] and homocysteine (umol/L). Measured via standard clinical laboratory assays.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Serum Measures of Lipids
Change from baseline of of lipids using fasting serum lipid panel to track cholesterol and fat levels. This includes: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL).
Measured: 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
Change from baseline of 24-hour urine analytes in aggregate to assess lithogenic risk. The analytes will include calcium (mg/day), creatinine (mg/day), citrate (mg/day), oxalate (mg/day), uric acid (mg/day), sodium (mmol/day), chloride (mmol/day), magnesium (mg/day), ammonium (mmol/day), sulfate (mmol/day), phosphorus (mg/day), urea nitrogen (g/day), and urine pH. Measured via standard clinical laboratory assays.
Measured: 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)
Change from baseline in glycemic variability includes mean glucose (mg/dL) measured over a period of time and compared to before and at the end of the Ren-Nu program. This will be measured using the FreeStyle Libre 3 System.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Anthropometric Measures
Change from baseline in body weight (kg) and body mass index (kg/m²), calculated from measured height and weight using standardized clinic procedures.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Blood Pressure
Change from baseline in systolic and diastolic blood pressure. Seated blood pressure (mmHg) is taken throughout the 4 week orientation period and the 12 week nutritional dietary program. This is measured using a calibrated automated blood pressure machine after 5 minutes of rest.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in Serum Fatty Acid
Change from baseline of serum free fatty acid (FFA, mmol/L).
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Secondary outcomes (5)
Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2)
Participants will complete the Quality of Life: Short-Form Health Survey 12 (SF-12v2) on Day 0 and Day 120. Scores are standardized by mean. A higher score indicates a better-than-average health-related quality of life, while a lower score suggests a below-average health-related quality of life.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in self reported mental and physical health outcomes
This is reported as a change in participant reported mental health status measured via both the Quality of Life: Short-Form Health Survey 12 (SF-12v2) and the study-developed Ren-Nu Outcomes survey. The outcomes survey assesses topics such as final weight (kg), final blood pressure (mmHg), current PKD related symptoms, and changes to medications/supplements.
Measured: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Assessment of nutrition knowledge following the structured nutrition education program
Self reported participant nutrition knowledge of the nutritional program at the end of the program. This is a study-developed questionnaire and these questions are multiple choice with a low score reflecting lower nutritional knowledge of the dietary program and a high score reflecting higher nutritional knowledge of the dietary program.
Measured: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention tolerability following the structured nutrition education program
Self reported participant tolerability of the nutritional program at the end of the program. This is a study-developed questionnaire and questions are multiple choice with a low score reflecting a lower tolerability to the dietary program and a high score reflecting higher satisfaction with the program.
Measured: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention feasibility following the structured nutrition education program
Self reported participant feasibility of the nutritional program at the end of the program. This is a study-developed questionnaire and questions are multiple choice with a low score reflecting lower feasibility of the dietary program and a high score reflecting higher feasibility of the dietary program.
Measured: Visit 3 (Day 120) after Ren-Nu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start25 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Fatica
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Barbara Nutrients
- Responsible party
- Sponsor-investigator, Richard Fatica, The Cleveland Clinic
- Investigators
- Richard Fatica, MD, Principal investigator, The Cleveland ClinicThomas Weimbs, PhD, Study director, Santa Barbara Nutrients
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454174
- Sponsor's protocol ID
- 24-893
- Other IDs
- SBN2504RF
- Acronym
- PKD-KETO
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT07454174
- Acronym / sponsor ID
- PKD-KETO / 24-893
- Keywords
- ADPKD, polycystic kidneys, Ren-Nu, KetoCitra, Keto diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Richard FaticaUniversity, hospital or other
- Collaborators
- Santa Barbara Nutrients
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of the Ren-Nu program aims to improve the metabolic health of ADPKD patients by implementing a plant-focused, kidney-safe, ketogenic diet supported by medical food KetoCitra®. It is a dietitian-led, online group program focused on ketogenic metabolic therapy with rolling recruitment .
For 12 weeks, participants will be remotely directed through the Ren-Nu program by an experienced renal dietitian where they will learn to implement diet and lifestyle changes by completing weekly web-based classes on nutrition principles and food preparation. A continuous glucose monitor (CGM) will be provided for use during the study. Additionally, they will use a smartphone application to track nutrient intake, self-monitor biomarkers, implement mindfulness practice, and participate in facilitated discussions to build community support. Each participant will meet remotely with the renal dietitian and complete laboratory safety monitoring throughout the program to tailor dietary recommendations for optimal compliance. The study will involve visits to the research institution, histories, physical examinations and laboratory work.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD | Experimental | Dietary Supplement: Ren-Nu and KetoCitraNutritional counseling and instruction in a ketogenic diet and nutritional food supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (18 years or older)
Key exclusion criteria (33 listed)
- Intolerance or allergy to any of the ingredients in the provided medical food
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ren-Nu and KetoCitraAlso: Continuous glucose monitoring, intermittent fasting, Nutritional counselingThis is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters | Dietary supplement | Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD |
Primary outcome
Change in Serum Renal Function
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.
Change in Serum Hepatic Function Biomarkers
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum liver panel biomarkers to track safety signals. Biomarkers include: AST (U/L), ALT (U/L), and LDH (U/L). Measured via standard clinical laboratory assays.
Change in Glycemic Control
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of glycemic control as measured by aggregate of Hgb A1c and Homeostatic model assessment of insulin resistance (HOMA-IR).
Change in Systemic Inflammation Markers
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of inflammatory biomarkers as an aggregate using: serum C-reactive protein [(CRP) mg/dL] and homocysteine (umol/L). Measured via standard clinical laboratory assays.
Change in Serum Measures of Lipids
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of of lipids using fasting serum lipid panel to track cholesterol and fat levels. This includes: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL).
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 from baseline of 24-hour urine analytes in aggregate to assess lithogenic risk. The analytes will include calcium (mg/day), creatinine (mg/day), citrate (mg/day), oxalate (mg/day), uric acid (mg/day), sodium (mmol/day), chloride (mmol/day), magnesium (mg/day), ammonium (mmol/day), sulfate (mmol/day), phosphorus (mg/day), urea nitrogen (g/day), and urine pH. Measured via standard clinical laboratory assays.
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 from baseline in glycemic variability includes mean glucose (mg/dL) measured over a period of time and compared to before and at the end of the Ren-Nu program. This will be measured using the FreeStyle Libre 3 System.
Change in Anthropometric Measures
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in body weight (kg) and body mass index (kg/m²), calculated from measured height and weight using standardized clinic procedures.
Change in Blood Pressure
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in systolic and diastolic blood pressure. Seated blood pressure (mmHg) is taken throughout the 4 week orientation period and the 12 week nutritional dietary program. This is measured using a calibrated automated blood pressure machine after 5 minutes of rest.
Change in Serum Fatty Acid
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum free fatty acid (FFA, mmol/L).
5 secondary outcomes
Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2)
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change in self reported mental and physical health outcomes
Time frame: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Assessment of nutrition knowledge following the structured nutrition education program
Time frame: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention tolerability following the structured nutrition education program
Time frame: Visit 3 (Day 120) after Ren-Nu
Assessment of dietary intervention feasibility following the structured nutrition education program
Time frame: Visit 3 (Day 120) after Ren-Nu
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Fatica, MD principal investigator
The Cleveland Clinic
Thomas Weimbs, PhD study director
Santa Barbara Nutrients
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ren-Nu and KetoCitra in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Richard Fatica at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloe Booth (216-444-5053, boothc2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.