The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients

Q: Who can participate in NCT05938712?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05938712?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Two Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of the Combined Use of Once Daily 10mg Dapagliflozin and Once Weekly 1.0mg Semaglutide in Kidney Transplant Recipients

The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients (NCT05938712) is a Phase 2 interventional studying Kidney Transplant Recipients, sponsored by University Health Network, Toronto. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Kidney Transplant Recipients and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed and dated written willing to sign a consent form. - Patients aged ≥18 years with KTR - \>3 months post kidney transplantation - Estimated glomerular filtration rate \[eGFR\] ≥20 ml/min/1.73m2 - BP \<160/100 and \>90/60 at screening - Body-mass index \[BMI\] between 18.5-40kg/m2 - In patients with T2D or PTDM, HbA1c \<12.0%; Who Should NOT Join This Trial: - 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, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome etc.). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion 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 \<160/100 and \>90/60 at screening * Body-mass index \[BMI\] between 18.5-40kg/m2 * In patients with T2D or PTDM, HbA1c \<12.0%; Exclusion Criteria: * 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, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome etc.).

Treatments Being Tested

DRUG

Dapagliflozin 10 MG

Semaglutide subcutaneous once weekly for 12 weeks.

DRUG

Semaglutide, 1.0 mg/mL

Dapagliflozin oral once daily for 12 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Toronto General Hospital

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05938712), the sponsor (University Health Network, Toronto), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05938712 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05938712?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05938712?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05938712. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05938712. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.