None listed
Conditions
Brief summary
The aim of this pilot study is to obtain data regarding the safety and tolerability of tirzepatide 15mg subcutaneous injection weekly for the treatment of obesity in adults with ESKD. Adults on haemodialysis with a BMI of 30kg/m2 or above who are potential candidates for kidney transplant will be recruited. All participants will receive tirzepatide once weekly, starting at a dose of 2.5mg and increasing every 4 weeks to a maximum dose of 15mg. Participants will receive tirzepatide treatment for a total of 24 weeks.
Interventions
This is a single-site, prospective, open-label, single-arm, 24-week intervention study of tirzepatide 15 mg subcutaneous injection weekly in patients with obesity and end-stage kidney disease (ESKD) on haemodialysis who are potential candidates for kidney transplant.
Tirzepatide will be administered weekly on the same day following the completion of a dialysis session by a dialysis nurse, or alternatively, self-administered by selected patients undergoing haemodialysis at home following specia
This is a single-site, prospective, open-label, single-arm, 24-week intervention study of tirzepatide 15 mg subcutaneous injection weekly in patients with obesity and end-stage kidney disease (ESKD) on haemodialysis who are potential candidates for kidney transplant. Tirzepatide will be administered weekly on the same day following the completion of a dialysis session by a dialysis nurse, or alternatively, self-administered by selected patients undergoing haemodialysis at home following specialised drug administration training. Adherence will further be monitored by fortnightly adverse event assessments, and regular pre- and post- dosing tirzepatide blood level monitoring.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or older at the time of enrolment Obesity (body mass index [BMI] of 30 kg/m2 or above) ESKD, requiring haemodialysis, at the time of enrolment Considered a potential candidate for kidney transplantation Can provide informed consent
Exclusion criteria
Previous or planned (during the trial period) bariatric surgery Type 1 diabetes History of acute or chronic pancreatitis Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary Thyroid carcinoma Proliferative diabetic retinopathy requiring acute treatment Pregnancy, lactation, or plan to become pregnant within 28 weeks of enrolment Known hypersensitivity to tirzepatide
Outcome results
None listed