60 Participants Needed

Weight Management for Obesity and Kidney Disease

HL
Overseen ByHeather LaPier, BSc
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Western University, Canada
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
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using more than the starting dose of certain medications like semaglutide, liraglutide, or dulaglutide.

What data supports the effectiveness of the drug Semaglutide for weight management in patients with obesity and kidney disease?

Research shows that Semaglutide, a drug used for diabetes, can help with weight loss and improve kidney function in people with obesity and kidney disease. It has been effective in reducing body weight and managing blood sugar levels, which can be beneficial for patients with these conditions.12345

Is the treatment safe for humans?

Semaglutide, marketed under names like Rybelsus, Ozempic, and Wegovy, has been shown to be safe in humans, including those with type 2 diabetes and chronic kidney disease. It is generally well-tolerated and has a good safety profile, with benefits such as weight loss and cardiovascular protection.26789

How is the drug Semaglutide unique for treating obesity and kidney disease?

Semaglutide is unique because it is a once-weekly injection that not only helps with weight loss but also improves kidney function by reducing albuminuria (protein in urine) and preserving kidney function, which is particularly beneficial for patients with chronic kidney disease.123410

What is the purpose of this trial?

OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.

Research Team

KK

Kristin K Clemens, MD, MSc

Principal Investigator

St. Joseph's Health Care London

LM

Louise Moist

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for individuals with obesity and high-risk chronic kidney disease (CKD) or those on dialysis, aiming to lose weight for a kidney transplant. Participants must be seeking to manage their weight and willing to engage in a virtual program.

Inclusion Criteria

I am at high risk for severe kidney failure or am on dialysis.
BMI > 35 kg/m^2

Exclusion Criteria

I do not have insurance coverage for semaglutide.
I have Type 1 diabetes.
I cannot have a kidney transplant due to health reasons.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vanguard Phase

Feasibility study to ensure recruitment and process inclusivity, and assess program acceptability

12 months

Treatment

Participants receive either usual care or a virtual weight management program with semaglutide and coaching

26 weeks
Virtual coaching once every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Semaglutide
  • Virtual Weight Management Coaching
Trial Overview The OK-TRANSPLANT 2 study is testing the effectiveness of virtual weight management coaching compared to usual care practices. Additionally, it will evaluate the use of Semaglutide, a medication that may aid in weight loss.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Weight Management ProgramExperimental Treatment2 Interventions
A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.
Group II: Usual CareActive Control1 Intervention
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇨🇦
Approved in Canada as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇯🇵
Approved in Japan as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Wegovy for:
  • Obesity
🇺🇸
Approved in United States as Rybelsus for:
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Lawson Health Research Institute

Collaborator

Trials
684
Recruited
432,000+

Unity Health Toronto

Collaborator

Trials
572
Recruited
470,000+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials
26
Recruited
14,200+

St. Michael's Hospital (Toronto, Canada)

Collaborator

Trials
1
Recruited
60+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Collaborator

Trials
668
Recruited
424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Trials
678
Recruited
421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Collaborator

Trials
686
Recruited
427,000+

Findings from Research

In the STEP 2 trial involving 1,205 participants, semaglutide (both 1.0 mg and 2.4 mg) significantly improved kidney function as measured by urine albumin-to-creatinine ratio (UACR), with reductions of -14.8% and -20.6% respectively, compared to an increase of +18.3% in the placebo group.
Across pooled data from STEP 1-3, semaglutide did not affect estimated glomerular filtration rate (eGFR) decline in participants with normal kidney function, indicating its safety in terms of kidney function preservation.
Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.Heerspink, HJL., Apperloo, E., Davies, M., et al.[2023]
Subcutaneous semaglutide (Ozempic®), a GLP-1 receptor agonist, has shown significant efficacy in improving glycemic control and reducing HbA1c, albuminuria, and blood pressure in patients with advanced diabetic kidney disease (DKD) during a 6-month follow-up study involving patients on maintenance hemodialysis.
The treatment not only aids in weight loss and appetite suppression but also helps preserve residual kidney function, potentially improving patient outcomes and facilitating their inclusion on kidney transplant waiting lists.
Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis.De la Flor, JC., Lorenzo, JD., Marschall, A., et al.[2022]
Two obese hemodialysis patients successfully lost weight using semaglutide, a GLP-1 receptor agonist, achieving a weight loss of 6.5 to 9.0 kg over 9 months, which is about 1 kg per month.
Semaglutide was well tolerated at a maximum dose of 1 mg/week, suggesting it could be a safe and effective alternative to bariatric surgery for weight management in patients with obesity and kidney disease.
Semaglutide for treatment of obesity in hemodialysis patients waiting for a kidney transplant: new hope?Touzot, M., Ureña-Torres, P., Dupuy, O.[2022]

References

Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. [2023]
Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis. [2022]
Semaglutide for treatment of obesity in hemodialysis patients waiting for a kidney transplant: new hope? [2022]
Influence of chronic kidney disease and its severity on the efficacy of semaglutide in type 2 diabetes patients: a multicenter real-world study. [2023]
Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials. [2020]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]
A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. [2023]
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]
Glucagon-like peptide 1(GLP-1) receptor agonists in the management of the patient with type 2diabetes mellitus and chronic kidney disease: an approach for the nephrologist. [2023]
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]
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