About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hemodialysis for more than 3 months (5 also with residual diuresis)
Age ≥18 years of age
Willing to sign informed consent
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Invokana 300 mg and 100 mg tablet
DrugA 600 mg dose of canagliflozin (two 300 mg tablets) will be administered orally by the participant
Treatment groups
Trial outcomes
Primary outcomes
Overall drug tissue disposition of SGLT2 in patients on dialysis.
The main outcome of the study is overall drug tissue disposition of SGLT2 in patients on dialysis. quantified by images obtained by PET imaging.
Secondary outcomes
Receptor occupancy of SGLT2 in the regions of interest.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: