Comparing Dapagliflozin with Semaglutide, 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
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
- Phase 2
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
Dapagliflozin 10 MG
Semaglutide subcutaneous once weekly for 12 weeks.
- Medication
Semaglutide, 1.0 mg/mL
Dapagliflozin oral once daily for 12 weeks.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Body-mass index \[BMI\] between 18.5-40kg/m2
- +Estimated glomerular filtration rate \[eGFR\] ≥20 ml/min/1.73m2
- +Signed and dated written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Patients aged ≥18 years with KTR
- +\>3 months post kidney transplantation
- +BP \<160/100 and \>90/60 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +In patients with T2D or PTDM, HbA1c \<12.0%;
Exclusion
- −With known or suspected hypersensitivity to semaglutide or related products
- −Type 1 diabetes.
- −History of multi-organ transplant
- −Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
- −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
- −Patient not able to understand and comply with study requirements, based on InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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.).
- −Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive one or more of: Dapagliflozin 10 MG and Semaglutide, 1.0 mg/mL.
Registry label: A: Semaglutide · B: Dapagliflozin
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 20 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to combination therapy end (24 weeks).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proximal tubular natriuresis with combination therapy — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to combination therapy end (24 weeks).
Proximal tubular natriuresis with monotherapy — measured over From baseline to monotherapy end (12 weeks).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05938712 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Dapagliflozin 10 MGDrug
Semaglutide subcutaneous once weekly for 12 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Semaglutide, 1.0 mg/mLDrug
Dapagliflozin oral once daily for 12 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to combination therapy end (24 weeks).
The study as a whole is currently expected to finish around 2028-03-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 20 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.