CANagliflozin In DIALysis Patients

Sponsor
University Medical Center Groningen
Study ID
NCT07527390
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Disease (Stages 4 and 5)
  • Dialysis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Invokana 300 mg and 100 mg tablet — DRUG
    A 600 mg dose of canagliflozin (two 300 mg tablets) will be administered orally by the participant

Study Details

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 Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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. ]

Central Contacts

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