meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jan 27, 2023

Keywords

ClinConnect Summary

The clinical trial titled "meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis" is investigating the safety and effects of a specific type of medication called SGLT2 inhibitors in people who are on peritoneal dialysis (a treatment for kidney failure) and still have some kidney function. The study aims to understand how this medication works in this group of patients and to ensure that it is safe for them to use.

To participate in this trial, individuals must be at least 18 years old and currently receiving peritoneal dialysis with a certain level of urine output and kidney function. They should also have had a stable treatment plan for their dialysis. However, there are some conditions that would exclude individuals from participating, such as having type 1 diabetes, recent serious heart or brain events, or certain other medical issues. Participants will be closely monitored throughout the study, and the research team will provide all necessary information and support. This trial is currently recruiting, so interested individuals should talk to their healthcare provider for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Planned surgery/procedures or radiologic investigations requiring contrast during the trial.
• • Pregnant, planning to become pregnant, or nursing an infant during the study period
• • History of any DKA event
• • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening.
• • Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
• • Alcohol or drug abuse within the 3 months prior to screening that would interfere with trial participation based on Investigator's judgement.
• • Use of SGLT2 inhibitor within 30 days prior to screening.
• • Intake of an investigational drug in another trial within 30 days prior to screening.
• • Patient not able to understand and comply with study requirements, based on Investigator's judgment.
• • Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome, severe hepatic impairments etc.).