meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated written informed consent.

Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml/min/1.73m2, as measured at least once in the last 3 months.

Stable PD prescription, as determined by investigators.

Stable dose of RAAS blockade if on a medication within this class for the last 30 days.

Disqualifiers

Type 1 diabetes.

Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.

PD peritonitis within 30 days of screening.

History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • Empagliflozin 25 MG

    Drug

    PO once daily

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EmpagliflozinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in measured GFR

GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection.

Time frame
Before and 2 weeks after initiation of empagliflozin.

Secondary outcomes

1

Rebound in GFR after Cessation of Therapy

A GFR measurement will be performed 2 weeks after cessation of empagliflozin, with the aim of capturing the reversible "rebound" in GFR after cessation of therapy.

Time frame
2 weeks
2

Change in ultrafiltration volume

Time frame
2 weeks
3

Change in fraction of glucose remaining in the dialysate

Time frame
2 weeks
4

Change in dialysate/plasma creatinine

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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