Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000665538
Ethics application status
Approved
Date submitted
3/05/2024
Date registered
24/05/2024
Date last updated
24/05/2024
Date data sharing statement initially provided
24/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Tirzepatide in kidney transplant candidates: a pilot study
Scientific title
Efficacy and tolerability of tirzepatide in the management of obesity in potential kidney transplant candidates with end-stage kidney disease: a pilot study
Secondary ID [1] 311768 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 333270 0
End-stage renal disease 333271 0
Condition category
Condition code
Renal and Urogenital 329965 329965 0 0
Kidney disease
Metabolic and Endocrine 329966 329966 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328221 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337725 0
Proportion of participants (%) at 24 weeks using a dose of 15 mg weekly tirzepatide
Timepoint [1] 337725 0
24 weeks post-commencement of tirzepatide injections
Secondary outcome [1] 432973 0
Proportion of participants (%) at 24 weeks who have discontinued treatment due to adverse effects.

Possible adverse effects of tirzepatide include nausea, vomiting, diarrhoea, constipation, gallstones, and acute pancreatitis.
Timepoint [1] 432973 0
24 weeks post-commencement of Tirzepatide injections
Secondary outcome [2] 432974 0
Change in body weight (%) at 24 weeks
Timepoint [2] 432974 0
24 weeks post-commencement of Tirzepatide injections

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26288 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 42259 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 316102 0
Hospital
Name [1] 316102 0
St Vincent's Hospital Melbourne Research Endowment Fund
Country [1] 316102 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318286 0
None
Name [1] 318286 0
Address [1] 318286 0
Country [1] 318286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314929 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314929 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314929 0
Australia
Date submitted for ethics approval [1] 314929 0
02/02/2024
Approval date [1] 314929 0
06/03/2024
Ethics approval number [1] 314929 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133166 0
A/Prof Priya Sumithran
Address 133166 0
Department of Medicine, St Vincent's Hospital Melbourne, Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy VIC 3065
Country 133166 0
Australia
Phone 133166 0
+61 3 9903 8939
Fax 133166 0
Email 133166 0
priyas@unimelb.edu.au
Contact person for public queries
Name 133167 0
Priya Sumithran
Address 133167 0
Department of Medicine, St Vincent's Hospital Melbourne, Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy VIC 3065
Country 133167 0
Australia
Phone 133167 0
+61 3 9903 8939
Fax 133167 0
Email 133167 0
priyas@unimelb.edu.au
Contact person for scientific queries
Name 133168 0
Priya Sumithran
Address 133168 0
Department of Medicine, St Vincent's Hospital Melbourne, Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy VIC 3065
Country 133168 0
Australia
Phone 133168 0
+61 3 9903 8939
Fax 133168 0
Email 133168 0
priyas@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.