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ESRDPhase 4SIP-AKiDNCT05309785

Safety and Efficacy of Canagliflozin in Advanced CKD

A Phase 4 study testing Invokana 300 mg and 100 mg tablet in people with ESRD and CKD Stage 4, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study objective is to characterize the pharmacokinetics (PK), pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD, including those receiving HD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ESRD, CKD Stage 4, CKD Stage 5
What is being tested?
Invokana 300 mg and 100 mg tablet
Type of treatment
Pill or oral medicine
How many people
34 participants
Where
1 siteCanada
Study dates
24 Nov 2022to 1 Jul 2026
Phase
Phase 4
Are there results?
None posted in the registry

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

  • (Substudy 1- SIP-AKiD-1):
  • adult patients with eGFR <30 ml/min/1.73m2
  • urine albumin to creatinine ratio (UACR) >200 mg/g
  • not receiving dialysis.
  • (Substudy 2- SIP-AKiD-2):
  • adult patients on hemodialysis for at least 3 months
  • without significant residual renal function, defined as a urine output <250 ml/24h.

Who cannot join

  • Age <18 years
  • type 1 diabetes
  • history of euglycemic ketoacidosis
  • known hypersensitivity to SGLT-2 inhibitors
  • recurrent severe genital or urinary tract infections
  • history of atraumatic amputation, gangrene, or active skin ulcer
Show all 13Show fewer
  • use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
  • liver disease defined by an ALT > 3.0 times the upper limit of normal [ULN] or total bilirubin >1.5 times the ULN or liver cirrhosis of any stage
  • gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
  • pregnancy
  • currently breastfeeding
  • any other clinical condition that would jeopardize patient safety while participating in this trial.
  • Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir will be excluded if these agents cannot be safely discontinued

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Center

    Montreal, Quebec

Other trials in Canada

About this study

The study objective is to characterize the pharmacokinetics (PK), pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD, including those receiving HD.

As the CV and renoprotective effects of SGLT-2 inhibitors appear to be independent of glycemic control, the investigators hypothesize that canagliflozin will reduce albuminuria in patients with advanced CKD in the same manner as observed in patients with higher eGFR. The investigators also hypothesize that the 300 mg dose will be equally safe as the 100 mg dose but will have greater efficacy, given data which suggests efficacy correlates with drug exposure in patients without CKD.

Given its negligible renal elimination, the investigators hypothesize that exposure to canagliflozin 100 mg at steady state will not exceed the standard bioequivalence boundary of 80-125% in patients receiving HD, compared with published estimates with the 300 mg dose at steady state in individuals with preserved kidney function.

Read the detailed description

Substudy 1:

Patients with eGFR<30 ml/min/1.73m2 and urine albumin to creatinine ratio (UACR)>200 mg/g not receiving dialysis will receive canagliflozin 100 mg po daily for 12 weeks (phase 1). For participants who have tolerated the drug, canagliflozin will be increased to 300 mg po daily for an additional 12 weeks (phase 2) and then stopped. Each phase will be followed by a 2-week window to ascertain surrogate efficacy outcomes.

Substudy 2:

Adult patients on HD for at least 3 months without significant residual renal function will receive canagliflozin 100 mg po daily for 9 days.

Being tested
Invokana 300 mg and 100 mg tablet
Keywords
Canagliflozin, Advanced CKD, ESRD, Hemodialysis, Safety, Efficacy, SGLT-2 inhibitor
Medical subject headings
Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Invokana 300 mg and 100 mg tabletDrug

    Also called Canagliflozin 300 mg and 100 mg tablet

    Substudy 1 Patients who fulfill the inclusion criteria and consent to participate will receive canagliflozin 100 mg po daily for 12+2 weeks (phase 1). For participants who have tolerated the drug, canagliflozin will be increased to 300 mg po daily for an additional 12+2 weeks (phase 2) and then stopped. If not tolerated, the dose will be reduced to 100 mg until the end of follow-up.

    Each phase of 12 weeks is followed by a 2-week window to ascertain surrogate efficacy outcomes.

    Substudy 2 Patients who fulfill the inclusion criteria and consent to participate will receive canagliflozin 100 mg po daily for 9 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 26-week change in albuminuria compared to baseline, as assessed by the UACR.

    For substudy 1

    Measured: 26 weeks

  2. The drug exposure at steady-state with 100 mg, as expressed by the AUC0-24, compared to published estimates with the 300 mg dose in patients with preserved renal function.

    For substudy 2

    Measured: 8 days

Secondary outcomes (6)

  1. Change in UACR with 300 mg (at 26 weeks) vs. 100 mg dose (at 12 weeks) vs. baseline

    For substudy 1

    Measured: At 12 and 26 weeks

  2. Change in 24-hour ambulatory blood pressure (BP)

    For substudy 1

    Measured: At 12 and 26 weeks

  3. Area under the plasma concentration versus time curve (AUC)

    For substudy 1

    Measured: At 12 and 26 weeks

  4. Change in 6-minute walk distance from baseline

    For substudy 1

    Measured: At 12 and 26 weeks

  5. Change in urinary excretion of sodium from baseline

    For substudy 1

    Measured: At 12 and 26 weeks

  6. Neutrophil gelatinase-associated lipocalin (NGAL) levels

    For substudy 1

    Measured: After ≥12 weeks of treatment with each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start24 Nov 2022
  3. Primary completion30 Apr 2026
  4. Study completion1 Jul 2026

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
We will conduct a single center, prospective, single-arm, open-label interventional study in 2 cohorts. Substudy 1: patients with advanced CKD, not yet on HD (N=36) Substudy 2: patients receiving HD (N=8)
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05309785
Sponsor's protocol ID
2022-8410
Acronym
SIP-AKiD
Status last verified
Jul 2026
First submitted
14 Mar 2022
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mavrakanas TA, Marsot A, Tsirella E, Rios N, Gritsas A, Suri RS. Canagliflozin Pharmacokinetics at Steady State in Patients on Maintenance Hemodialysis. Kidney Int Rep. 2024 Aug 8;9(10):3049-3052. doi: 10.1016/j.ekir.2024.07.038. eCollection 2024 Oct. No abstract available.

    PubMed 39430196

  • Elenjickal EJ, Mavrakanas TA, Gritsas A, Suri RS, Marsot A. Population Pharmacokinetic Modeling of Canagliflozin in Advanced Chronic Kidney Disease. Clin Pharmacokinet. 2025 Nov;64(11):1693-1708. doi: 10.1007/s40262-025-01571-8. Epub 2025 Sep 15.

    PubMed 40952584

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Invokana 300 mg and 100 mg tablet in people with ESRD and CKD Stage 4, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 26-week change in albuminuria compared to baseline, as assessed by the UACR. (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05309785, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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