The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
- Sponsor
- University Health Network, Toronto
- Study ID
- NCT05938712
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Kidney Transplant Recipients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin 10 MG — DRUGSemaglutide subcutaneous once weekly for 12 weeks.
- Semaglutide, 1.0 mg/mL — DRUGDapagliflozin oral once daily for 12 weeks.
Study Details
The study aims to determine the short-term efficacy, mechanisms and safety of 12 weeks of dapagliflozin and semaglutide combination therapy in 20 KTR, with and without T2D.
Key Dates
- Start date
- Oct 24, 2023
- Status verified
- Apr 2026
- Primary completion
- Oct 1, 2027
- Completion
- Mar 1, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: SemaglutideSemaglutide Subcutaneous 0.25mg once weekly for 4 weeks, then 0.5mg once weekly for 4 weeks, then 1mg once weekly for 4 weeks.
- Experimental: DapagliflozinDapagliflozin Tablets Total Dose 10mg daily for 12 weeks
Primary Outcome Measure
Proximal tubular natriuresis with combination therapy [ Time Frame: From baseline to combination therapy end (24 weeks) ]
Central Contacts
- Vesta Lai416-340-4800
Related Studies
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- Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant RecipientsPHASE4 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts