Recruiting NA Polycystic Kidney Disease

New treatment option for Polycystic Kidney Disease

Official title Well-Formulated Ketogenic Diet Polycystic Kidney Disease

ClinicalTrials.gov ID: NCT06325644

What this study is testing

What is Ketone/Glucose Monitoring?

Ketone/Glucose Monitoring is an investigational medicine, given as an once-daily, being studied as a potential treatment for polycystic kidney disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • Age 18-65 years old
  • Diagnosis of ADPKD by imaging and/or genetic testing
  • GFR ≥ 25 mg/dl
  • Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR...
  • No changes of medications within the last three months.

You likely can't join if

  • Patients currently being treated with Tolvaptan
  • Diagnosed with diabetes.
  • Pregnancy
  • Contraindications to MRI
  • Ketogenic diet within the last three months
  • Severe kidney disease with GFR \< 25 mg/dl
See the full eligibility criteria
Who can join
  • Age 18-65 years old
  • Diagnosis of ADPKD by imaging and/or genetic testing
  • GFR ≥ 25 mg/dl
  • Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1...
  • No changes of medications within the last three months.
  • Able to comply with dietary intervention
  • Ability to sign informed consent
What rules you out
  • Patients currently being treated with Tolvaptan
  • Diagnosed with diabetes.
  • Pregnancy
  • Contraindications to MRI
  • Ketogenic diet within the last three months
  • Severe kidney disease with GFR \< 25 mg/dl
  • Unable to purchase food for the diet intervention
  • Gastrointestinal disorders that will interfere with diet intervention
  • Chronic alcohol or drug abuse

The study team makes the final eligibility decision.

Where it's taking place

  • Columbus, 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 to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Columbus, 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.