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Could a keto diet help slow kidney disease? new study seeks answers

NCT ID NCT07454174

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 16-week nutritionist-led ketogenic diet program (Ren-Nu) with a medical food called KetoCitra in 20 adults with autosomal dominant polycystic kidney disease (ADPKD). The goal is to see if the diet can improve kidney function and other health markers while monitoring safety. Participants must be 18 or older, have a confirmed ADPKD diagnosis, and have moderate kidney function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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Other studies related to the condition(s) this trial covers.