CANAGLIFLOZIN for Chronic kidney disease stage 5 | Chronic Kidney disease

Inclusion criteria

• {"criterion_text":"- 1) Dialysis for more than 3 months both HD and PD (5 also with residual diuresis)\n- 2) Age ≥18 years of age\n- 3) Willing to sign informed consent"}

Exclusion criteria

• {"criterion_text":"- 1) Mentally incapacitated subjects (i.e. not able to sign informed consent) 2) 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. 3) Pregnant women and women of child-bearing potential who are not using reliable contraception 4) Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening 5) Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day 6) History of hypersensitivity to canagliflozin or another SGLT2 inhibitor 7) Severe claustrophobia 8) 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. 9) 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 10) Established peripheral arterial disease 11) Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission < 3 months before inclusion 12) People using digoxin 13) Patients with an active malignancy"}

Primary endpoints

• {"endpoint_text":"- The overall percentage of receptor occupancy.","definition_or_measurement_approach":"Measured by visualising tissue distribution using 18F-canagliflozin (PET imaging) as described in the main objective."}

Secondary endpoints

• {"endpoint_text":"- The percentage of receptor occupancy in the specific regions of interest.","definition_or_measurement_approach":"Measured in specific regions of interest (proximal tubule of the kidney, cardiac tissue, vascular tissue, brain tissue) using 18F-canagliflozin PET imaging."}
• {"endpoint_text":"- The overall percentage of receptor occupancy compared between dialysis patients that have and that do not have residual diuresis.","definition_or_measurement_approach":"Comparison of overall receptor occupancy between patient subgroups with and without residual diuresis (measured by 18F-canagliflozin PET imaging)."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

20

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"14","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"15: Expertise nuclear medicine","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"15: Expertise nuclear medicine","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"13","organisation_type":"Hospital/Clinic/Other health care facility"}