Recruiting PHASE4 Kidney Disease, Chronic

New treatment option for Kidney Disease, Chronic

Official title Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis

ClinicalTrials.gov ID: NCT07017270

What this study is testing

What is Semaglutide Pen?

Semaglutide Pen is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for kidney disease, chronic.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥ 18
  • Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
  • confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
  • Ability to provided informed consent or through their substitute decision maker

You likely can't join if

  • Type 1 DM
  • Use of a GLP-1-RA within 30 days prior to screening
  • Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute...
  • Confirmed pregnancy, women of childbearing potential
  • Known hypersensitivity to GLP-1-RA
  • Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
See the full eligibility criteria
Who can join
  • Age ≥ 18
  • Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
  • confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
  • Ability to provided informed consent or through their substitute decision maker
What rules you out
  • Type 1 DM
  • Use of a GLP-1-RA within 30 days prior to screening
  • Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)
  • Confirmed pregnancy, women of childbearing potential
  • Known hypersensitivity to GLP-1-RA
  • Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
  • Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA

The study team makes the final eligibility decision.

Where it's taking place

  • Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.