A Phase 2 interventional study of Canagliflozin 300 MG in ESRD and CKD (Chronic Kidney Disease) Stage 5D, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2, Interventional, and Treatment
This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD.
The primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.
Patients with kidney failure on peritoneal dialysis who meet the study inclusion criteria will be randomized at a 2:2:1 ratio to one of the following arms:
(i) canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by matching placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label).
(ii) placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label).
(iii) standard of care, with no active treatment, for 26 weeks (open label). Four in-person and one phone study visits have been scheduled: baseline visit, week 5, week 10, week 18 (phone visit), and week 26. A standardized peritoneal equilibration test (PET) will be performed at each of the in-person visits. There will also be two safety assessments at weeks 2 and 7, which will consist of blood tests. Patients who develop intercurrent illnesses or are hospitalized may temporarily discontinue the study drug if deemed appropriate by the treating physician.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
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Exclusion Criteria:
Canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by matching placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label)
Drug: Canagliflozin 300 MG
Placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label)
Drug: Canagliflozin 300 MG
Standard of care, with no active treatment, for 26 weeks (open label)
Canagliflozin 300 mg once daily
Also known as: Invokana 300 mg
Change in D4/D0
Change in the ratio of intraperitoneal glucose at 0 and 4h post infusion (D4/D0 ratio) in a standardized PET with canagliflozin, compared with placebo.
Time frame: 5 and 10 weeks from baseline
Change in ultrafiltration
Change in ultrafiltration, as assessed by the volume of drain after a 4h dwell with 2 L of a 2.5% dextrose solution minus the volume infused, with canagliflozin compared with placebo.
Time frame: 5 and10 weeks from baseline
Change in sodium dip/ sieving
Change in sodium dip/ sieving, calculated as the absolute difference in dialysate sodium at 0 and 1h post infusion in a standardized PET, with canagliflozin compared with placebo.
Time frame: 5 and 10 weeks from baseline
Change in small solute clearance
Change in small solute clearance, as assessed by the dialysate-to-plasma (D/P) creatinine and urea at the end of a 4h-dwell, with canagliflozin compared with placebo.
Time frame: 5 and10 weeks from baseline
Canagliflozin levels in the dialysate
Canagliflozin levels in the dialysate at 5 and 10 weeks, as assessed by mass spectrometry
Time frame: 5 and10 weeks from baseline
Change in small and middle solute clearance
Change in small and middle solute clearance using weekly Kt/V urea, weekly creatinine clearance, clearance of β2-microglobulin, and modifications in PD prescription.
Time frame: 26 weeks from baseline
Change in effluent biomarker levels
Change in effluent biomarker levels at 26 weeks from baseline. The panel of biomarkers includes interleukin-6 (IL-6), monocyte chemoattractant protein-1 (MCP-1), vascular endothelial growth factor (VEGF), cancer antigen-125 (CA-125), plasminogen activator inhibitor-1 (PAI-1), and decoy recptor-2 (eDcR2), assessed by using enzyme-linked colorimetric immunoassays.
Time frame: 26 weeks from baseline
Change in residual kidney function
Change in residual kidney function, as assessed by the 24h urine output and 24h native urea and creatinine clearance
Time frame: 26 weeks from baseline
Change in blood pressure
Change in 24h-ambulatory blood pressure measurements at 26 weeks from baseline
Time frame: 26 weeks from baseline
6-minute walk test
Change in distance in the 6-minute walk test at 26 weeks from baseline
Time frame: 26 weeks from baseline
Change in dyspnea score
Change in dyspnea score using the 7-point Likert scale and Visual analog scale questionnaire at 26 weeks from baseline
Time frame: 26 weeks from baseline
Change in quality of life
Difference in quality of life using the Kidney Disease Quality of Life questionnaire at 26 weeks from baseline
Time frame: 26 weeks from baseline
Major adverse cardiovascular events
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure
Time frame: 26 weeks from baseline
Death from any cause
Death from any cause
Time frame: 26 weeks from baseline
Safety outcomes
Safety outcomes, including serious adverse events and any adverse events
Time frame: 26 weeks from baseline
Feasibility outcome
Ability to recruit for the study at the anticipated average recruitment rate and study completion with at least 80% adherence with reasons for non-adherence being reported
Time frame: 26 weeks from baseline
Plan to share: Yes — An anonymized dataset may be shared with other investigators in the future after the publication of primary results of this clinical trial. Any request for data sharing will have to be approved by the clinical trial steering committee after having examined the data sharing proposal. A data use agreement will be required through the Contracts Office of the Research Institute of McGill University Health Center.
Supporting information: Study protocol, Sap, Csr, Analytic code
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McGill University Health Centre/Research Institute of the McGill University Health Centre