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A study of canagliflozin and 18F-canagliflozin in patients with chronic kidney disease undergoing dialysis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to investigate how a certain type of medication works in people living with Chronic Kidney Disease, a condition where the kidneys do not work as well as they should. The research focuses on individuals undergoing dialysis, a medical procedure used to clean the blood when the kidneys can no longer do so on their own. The study examines how SGLT2 inhibitors, a class of drugs used to manage certain conditions, are distributed within the body's tissues.

The medications involved include canagliflozin, which is taken as a tablet, and a special version called 18F-canagliflozin. This second substance is a tracer used for PET imaging, a type of scan that allows doctors to see how substances move through the body. Participants will receive the medication through an intravenous administration, which means it is delivered directly into a vein through a needle. The study will also observe how these substances behave in patients with or without residual diuresis, which refers to the body's remaining ability to produce urine.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    An oral dose of 600 mg of canagliflozin (in the form of film-coated tablets) is taken.

    This medication is used as part of the study to examine how certain substances work in the body.

  2. Step 2

    Imaging procedure

    A solution for injection containing 200 mbq of 18F-canagliflozin is administered through an intravenous line, which means it is delivered directly into a vein.

    This substance is used to help visualize and study how specific substances are distributed within the body's tissues.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older.
  • You must have been undergoing dialysis, which is a medical treatment that cleans your blood when your kidneys can no longer do it effectively, for more than 3 months.
  • This includes patients using hemodialysis (using a machine to clean the blood) or peritoneal dialysis (using a special fluid in the abdomen to clean the blood).
  • Participants may also have residual diuresis, which means the body is still able to produce some urine on its own.
  • You must be willing to sign an informed consent form, which is a document that explains all the details, risks, and benefits of the study before you agree to join.

Who cannot join the trial?

16 criteria

  • People who are mentally incapacitated, which means they are unable to understand the study and sign the legal form to give their permission.
  • People who have had too much radiation exposure, which is a type of energy that can pass through the body, in the past year.
  • Pregnant women or women who could become pregnant and are not using a reliable form of contraception (birth control).
  • People taking diuretics (water pills that help the body get rid of extra fluid) whose dose has changed in the last 4 weeks.
  • People already taking an SGLT2 inhibitor (a type of medicine for blood sugar) who have not stopped taking it for at least 1 week.
  • Anyone with a history of hypersensitivity, which means an allergic reaction, to canagliflozin or similar medicines.
  • People with severe claustrophobia, which is an extreme fear of being in small or enclosed spaces.
  • People with a history of drug or alcohol abuse in the last 12 months, or if blood tests show signs of such use.
  • People who have had major gastrointestinal surgery, which involves the stomach or intestines, such as having parts of the stomach or bowel removed.
  • People who had gastrointestinal ulcers (sores in the stomach or intestines) or bleeding in the stomach or rectum in the last six months.
  • People who had pancreatitis, which is an inflammation or injury to the pancreas, in the last six months.
  • People with hepatic disease (liver disease), specifically if liver enzyme levels are very high or if they have a history of liver-related complications.
  • People with peripheral arterial disease, which is a condition where narrowed blood vessels reduce blood flow to the limbs.
  • People with active cardiovascular disease, such as a recent heart attack, chest pain, heart surgery, stroke, or heart failure (a condition where the heart cannot pump enough blood), within the last 3 months.
  • People who are currently taking digoxin (a medicine used for certain heart conditions).
  • People with an active malignancy, which is a term for an ongoing cancer.
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Investigated drugs

Canagliflozin is a medication used to help manage blood sugar levels. In this study, it is being used in two ways: one version is given through a vein to help researchers see how the medicine moves through the body's tissues, and the other is taken as a pill to study its effects in patients undergoing dialysis.

What is already known about the treatment

  • 18F-Canagliflozin

    This medication is an experimental imaging agent provided as a solution for injection into a vein. Currently being studied in clinical research, it is used to help doctors visualize how certain drugs distribute within body tissues using advanced scanning technology. It works by attaching a radioactive marker to the canagliflozin molecule, allowing it to target and highlight specific proteins in the body. This substance is classified as a radiopharmaceutical used for diagnostic imaging purposes.

  • Invokana

    This medication is an oral tablet taken by mouth to help manage blood sugar levels in people with type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors, which work by preventing the kidneys from reabsorbing sugar back into the blood, instead allowing the excess sugar to leave the body through urine. While widely used in medical practice, its effects are also being studied in patients with kidney conditions to better understand its behavior. It is pharmacologically classified as an antidiabetic agent.

Investigated diseases

Chronic kidney disease - This condition occurs when the kidneys gradually lose their ability to filter waste products from the blood. As the kidneys become damaged, they cannot maintain the proper balance of fluids and minerals in the body. The process often happens slowly over many years. Over time, the filtering units within the kidneys may decrease in function. This decline can lead to a buildup of substances that are normally removed by the kidneys.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522742-46-00Protocol code20725Estimated enrolment10 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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