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Tests treatment safety and results for Kidney Transplant Recipients
Official title The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT05938712
What this study is testing
What is Dapagliflozin 10 MG?
Dapagliflozin 10 MG is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for kidney transplant recipients.
Also referred to as FARXIGA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent.
- Patients aged ≥18 years with KTR
- \>3 months post kidney transplantation
- Estimated glomerular filtration rate [eGFR] ≥20 ml/min/1.73m2
- BP \ 90/60 at screening
You likely can't join if
- Type 1 diabetes.
- History of multi-organ transplant
- Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
- Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening
- Actively treated BK, CMV or EBV infection
- Recurrent pyelonephritis or need for indwelling or self-catheterization
See the full eligibility criteria
- Signed and dated written informed consent.
- Patients aged ≥18 years with KTR
- \>3 months post kidney transplantation
- Estimated glomerular filtration rate [eGFR] ≥20 ml/min/1.73m2
- BP \ 90/60 at screening
- Body-mass index [BMI] between 18.5-40kg/m2
- In patients with T2D or PTDM, HbA1c \<12.0%;
- Type 1 diabetes.
- History of multi-organ transplant
- Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
- Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening
- Actively treated BK, CMV or EBV infection
- Recurrent pyelonephritis or need for indwelling or self-catheterization
- Prior amputation or ischemic rest pain
- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
- History of pancreatitis
- Personal or family history or medullary thyroid cancer or MEN2B
- History of unstable diabetic retinopathy within 1 year prior to screening
- Use of SGLT2i or GLP-1RA within 30 days prior to screening.
- Current and frequent episodes of hypoglycemia
- Current history of DKA requiring medical intervention or hospitalization
- With current risk of volume depletion, hypotension and/or electrolyte imbalance
- With known or suspected hypersensitivity to semaglutide or related products
- Patient not able to understand and comply with study requirements, based on Investigator's judgment.
- Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.