SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
Recruiting
Phase 4
Interventional Study
Kidney Transplantation Recipients
Sodium-Glucose Transporter 2 Inhibitors
Non-Diabetic Patients
Randomized Controlled Trial
Placebo Control Design
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 88 (estimated)
- Sponsor
- Odense University Hospital · Other
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About This Trial
This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients.
The main questions it aims to answer are:
* Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients?
* I…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Obtained written informed consent
* Male or female patients, age ≥ 18 years.
* Non-diabetic KTR
* \> 6 months post-transplant
* eGFR\> 25 ml/min/1.73m2 within the last 3 months pre randomization
* Immunosuppressive must include Tacrolimus
* Negative plasma hCG in fertile women…
Contacts