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NCT07527390

PHASE4

CANagliflozin In DIALysis Patients

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2027-01-30

Last Updated

2026-05-06

Healthy Volunteers

Conditions

Dialysis Chronic Kidney Disease (Stages 4 and 5)

Interventions

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

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

Locations (1)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands