Kidney Transplant; ComplicationsPhase 4NCT06140537
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Kidney Transplant; Complications and Vascular Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplant; Complications, Vascular Diseases, Diabetes
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Kidney transplant received 1 year prior to randomization
- estimated glomerular filtration rate 30-90 ml/min/1.73m2
- Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
- Pre-existing type 2 diabetes or post-transplant diabetes mellitus
- Blood pressure <130/80 mm Hg prior to randomization
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- Able to provide informed consent
- Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone
- Stable anti-hypertensive regimen for at least 1month prior to baseline
- Stable diabetes management for at least 3 months prior to baseline
- Stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)
- Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)
Who cannot join
- Type 1 diabetes
- Anticipated life expectancy <1 year
- Uncontrolled hypertension
- Hemoglobin A1c >9%
- Body mass index >40 kg/m2
- New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months
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- Pregnancy, plans to become pregnant, or breastfeeding
- Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors
- Current urinary or urogenital infection
- Use of anticoagulants (contraindication to kidney biopsy)
- Magnetic resonance imaging (MRI) contraindications
- History of lower-limb amputation irrespective of etiology
- Known hypersensitivity to dapagliflozin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Petter Bjornstad contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Rachael Reddin, Rachael.Reddin@cuanschutz.edu
About this study
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Medical subject headings
- Vascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin 10mg orally daily
PlaceboDrug
Placebo one tablet orally daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Participants will receive dapagliflozin 10mg daily Receives: Drug: Dapagliflozin 10mg Tab |
| Placebo | Placebo comparator | Participants will receive one placebo tablet daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuminuria
Measured by urine albumin to creatinine ratio
Measured: Change from baseline to 12 months
Secondary outcomes (7)
Kidney fibrosis
Measured by Magnetic Resonance Imaging (MRI) and kidney biopsy tissue
Measured: Change from baseline to 12 months
Kidney oxygenation
Measured by MRI
Measured: Change from baseline to 12 months
Arterial stiffness
Measured by aortic pulse wave velocity
Measured: Change from baseline to 12 months
Left ventricular mass
measured by cardiac MRI
Measured: Change from baseline to 12 months
estimated glomerular filtration rate
estimated by CKD epi equation
Measured: Change from baseline to 12 months
Kidney morphometry, metabolomics from paired kidney biopsies
measured by single cell RNA sequencing from paired kidney biopsies
Measured: Change from baseline to 12 months
safety and tolerability
assessed on basis of adverse events
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Feb 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140537
- Sponsor's protocol ID
- 23-1360
- Status last verified
- May 2025
- First submitted
- 14 Nov 2023
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06140537
- Acronym / sponsor ID
- 23-1360
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg TabParticipants will receive dapagliflozin 10mg daily |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive one placebo tablet daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-80 years
- Kidney transplant received 1 year prior to randomization
- estimated glomerular filtration rate 30-90 ml/min/1.73m2
- Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
- Pre-existing type 2 diabetes or post-transplant diabetes mellitus
Key exclusion criteria (13 listed)
- Type 1 diabetes
- Anticipated life expectancy <1 year
- Uncontrolled hypertension
- Hemoglobin A1c >9%
- Body mass index >40 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabDapagliflozin 10mg orally daily | Drug | Dapagliflozin |
| PlaceboPlacebo one tablet orally daily | Drug | Placebo |
Primary outcome
Albuminuria
Time frame: Change from baseline to 12 months
Measured by urine albumin to creatinine ratio
7 secondary outcomes
Kidney fibrosis
Time frame: Change from baseline to 12 months
Kidney oxygenation
Time frame: Change from baseline to 12 months
Arterial stiffness
Time frame: Change from baseline to 12 months
Left ventricular mass
Time frame: Change from baseline to 12 months
estimated glomerular filtration rate
Time frame: Change from baseline to 12 months
Kidney morphometry, metabolomics from paired kidney biopsies
Time frame: Change from baseline to 12 months
safety and tolerability
Time frame: baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petter Bjornstad contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Kidney Transplant; Complications and Vascular Diseases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kendrick (3037244837, Jessica.Kendrick@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albuminuria (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.