Semaglutide + Virtual Support for Obesity in Chronic Kidney Disease

(PIVOT Trial)

Not yet recruiting at 1 trial location
HL
Overseen ByHeather LaPier
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Kristin Clemens
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.

The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.

The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.

Who Is on the Research Team?

KC

Kristin Clemens, MD

Principal Investigator

St. Joseph's Health Care London, Western University

LM

Louise Moist, MD

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for people with advanced chronic kidney disease who are also living with obesity and may need a kidney transplant. It aims to include adults from diverse backgrounds, including those of lower income and different races.

Inclusion Criteria

BMI greater than 35 kg/m2
I am 18 years old or older.
eGFR less than 15 ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater

Exclusion Criteria

I do not have any conditions that prevent me from taking GLP-1RA medications.
I have type 1 diabetes.

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide
  • Virtual Weight Management Coaching

Trial Overview

The study tests a program combining virtual weight management coaching (diet and activity support) with the medication semaglutide (Ozempic), compared to usual care, to help patients lose weight safely before possible kidney transplantation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Weight Management ProgramExperimental Treatment2 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kristin Clemens

Lead Sponsor