ESRDPhase 2CAN-PDNCT06913647
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
A Phase 2 study testing Canagliflozin 300 MG in people with ESRD and CKD (Chronic Kidney Disease) Stage 5D, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD, CKD (Chronic Kidney Disease) Stage 5D
- What is being tested?
- Canagliflozin 300 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2026to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with kidney failure on PD (both incident and prevalent) who are on a stable prescription of dextrose-based solutions for at least 3 months.
- Only high or high-average transporters, as classified by PET, will be included.
Who cannot join
- History of euglycemic ketoacidosis
- Known hypersensitivity to canagliflozin
- Active peritonitis or tunnel infection
- Kidney transplant scheduled in the next 6 months
- Severe liver cirrhosis (Child-Pugh class C stage)
- Recurrent severe genital or urine infections
- Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these agents cannot be safely discontinued
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research Institute-McGill University Health Center
Montreal, Quebec
Efrosyne Tsirella, 5149341934 ext. 37836, efrosyne.tsirella@muhc.mcgill.ca
Norka Rios, 514-934-1934 ext. 35207, norka.rios@muhc.mcgill.ca
About this study
Official title: Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial
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.
Read the detailed description
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.
- Conditions
- ESRD, CKD (Chronic Kidney Disease) Stage 5D
- Being tested
- Canagliflozin 300 MG
- Keywords
- SGLT-2 inhibitors, Canagliflozin, Ultrafiltration failure, Peritoneal fibrosis, Peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Peritoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 300 MGDrug
Also called Invokana 300 mg
Canagliflozin 300 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Active treatment followed by placebo | Active comparator | 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) Receives: Drug: Canagliflozin 300 MG |
| Placebo followed by active treatment | Placebo comparator | 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) Receives: Drug: Canagliflozin 300 MG |
| Standard of care | No intervention | Standard of care, with no active treatment, for 26 weeks (open label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 and 10 weeks from baseline
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 26 weeks from baseline
Change in blood pressure
Change in 24h-ambulatory blood pressure measurements at 26 weeks from baseline
Measured: 26 weeks from baseline
6-minute walk test
Change in distance in the 6-minute walk test at 26 weeks from baseline
Measured: 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
Measured: 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
Measured: 26 weeks from baseline
Major adverse cardiovascular events
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure
Measured: 26 weeks from baseline
Death from any cause
Death from any cause
Measured: 26 weeks from baseline
Safety outcomes
Safety outcomes, including serious adverse events and any adverse events
Measured: 26 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Feb 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Thomas Mavrakanas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Thomas A. Mavrakanas, MD, MSc., Principal investigator, Research Institute-McGill University of Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913647
- Sponsor's protocol ID
- 2025-11346
- Other IDs
- 2025
- Acronym
- CAN-PD
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.