CANagliflozin In DIALysis Patients (CANIDIAP)

April 29, 2026 updated by: University Medical Center Groningen

Rationale:

Sodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Secondary analyses from these trials demonstrated that these benefits were consistent in patients with or without type 2 diabetes and with or without chronic kidney disease (CKD) with a lower eGFR threshold of 20 mL/min/1.73m2. However, it is not yet clear if these drugs can also be used in patients with severe kidney disease who require dialysis. This is in part explained because SGLT2 inhibitors bind to a transporter which is located in the luminal side of proximal tubes in the kidney. If kidney function is low, and these patients have no or limited filtering capacity, it is possible that the efficacy of these drugs decrease. Notwithstanding, several animal experiments and preliminary clinical data have suggested that these drugs do have kidney and cardiac protective effects in case of severely decreased kidney function.

The investigators hypothesize that SGLT2 inhibitors are distributed to several tissues in the body on top of the kidney and therefore the investigators would like to investigate the specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Main objective:

The main objective of this exploratory study is to investigate specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis and visualize this by the use of 18F- canagliflozin.

Secondary objective:

To investigate 18F- canagliflozin binding in specific regions of interest:

  • The proximal tubule of the kidney
  • Cardiac tissue
  • Vascular tissue
  • Brain tissue

To compare whether tissue distribution is different between dialysis patients who have and that do not have residual diuresis.

Study design:

This is an open-label exploratory study. The study will consist of a screening visit and 2 study days, separated by a one-week interval.

Study population:

The trial population will consists of 10 patients ≥18 years of age who are on dialysis for more than 3 months with or without residual diuresis and as exclusion criteria a total cumulative radiation burden above 1mSv per year (from the age of 18 years), a history of hypersensitivity to canagliflozin, any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications or peripheral/cardiovascular disease.

Interventions:

On both study days, a blood sample will be obtained for routine clinical care. A non-diagnostic CT scan will be performed to optimally position the individual participant for the PET scan. In all participants, two 60-minute PET scans will be obtained. On the first study day, following IV radiotracer administration, a baseline 60-minute PET scan will be taken to measure uptake and accumulation of 18F- canagliflozin. On the second study day (approximately 1 week after the first study day), following oral administration of 600 mg canagliflozin, a second IV radiotracer dose will be administered followed by a 60- minute PET scan (post-drug). Venous lines will be placed prior to the PET-scans to inject the dose and for venous sampling. In this study venous sampling was implemented as arterial sampling appeared to be burdensome for both personnel and participants.

Main study endpoint:

The main endpoint of the study is overall drug tissue disposition of SGLT2 in patients on dialysis quantified by images obtained by PET imaging.

Secondary study endpoint:

Receptor occupancy of SGLT2 in the regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) as quantified by images obtained by PET imaging.

Study visits:

Screening visit, study day 1, study day 2.

Sample size:

The sample size planned for this study is 10 participants, allocated n=5 to the residual diuresis group and n = 5 to the non-residual diuresis group. The sample size is based on prior experience of a variability and feasibility study with 18-F canagliflozin in a cohort of 9 patients with T2DM.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713 GZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Hemodialysis for more than 3 months (5 also with residual diuresis)
  • Age ≥18 years of age
  • Willing to sign informed consent

Exclusion criteria:

  • Mentally incapacitated subjects (i.e. not able to sign informed consent)
  • Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years.
  • Pregnant women and women of child-bearing potential who are not using reliable contraception
  • Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening
  • Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be inter-rupted 1 week prior to the first study day till the end of the second study day (as the half-life is 10-13 hours a wash-out of the study drug of at least 7-days should be considered)
  • History of hypersensitivity to canagliflozin or another SGLT2 inhibitor
  • Severe claustrophobia
  • History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.

  • Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:

    • Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
    • Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months
    • Pancreatic injury or pancreatitis within the last six months
    • Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
    • Use of rifampicin and cholestryramine
  • Established peripheral arterial disease
  • Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous translu-minal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission < 3 months before inclusion
  • People using digoxin and/or lithium
  • Patients with an active malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotracer 18F- canagliflozin
On the first study day the radiotracer 18F- canagliflozin will be administered intravenously. On the second study day, following oral administration of 600 mg of canagliflozin, a second radiotracer dose of 18F- canagliflozin will be administered intravenously.
Drug: Invokana 300 mg and 100 mg tablet
A 600 mg dose of canagliflozin (two 300 mg tablets) will be administered orally by the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall drug tissue disposition of SGLT2 in patients on dialysis.
Time Frame: From enrollment to the second study day, seperated by approximately one-week intervals.
The main outcome of the study is overall drug tissue disposition of SGLT2 in patients on dialysis. quantified by images obtained by PET imaging.
From enrollment to the second study day, seperated by approximately one-week intervals.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receptor occupancy of SGLT2 in the regions of interest.
Time Frame: From enrollment to the second study day, seperated by approximately one-week intervals.
Receptor occupancy of SGLT2 in the regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) as quantified by images obtained by PET imaging.
From enrollment to the second study day, seperated by approximately one-week intervals.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20725 (DAIDS ES)
  • 2025-522742-46-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dialysis

Clinical Trials on Invokana 300 mg and 100 mg tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe