Kidney Transplant RecipientsPhase 3INFINITI2019NCT04965935
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients
A Phase 3 study testing Dapagliflozin 10 MG Oral Tablet in people with Kidney Transplant Recipients and Post-transplant Diabetes Mellitus, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant Recipients, Post-transplant Diabetes Mellitus, Type 2 Diabetes
- What is being tested?
- Dapagliflozin 10 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2021to 30 Aug 2024
- Phase
- Phase 3
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females >18 years old ≥ 6months after kidney transplantation;
- In patients with T2D or PTDM, HbA1c <12.0%;
- eGFR ≥30 ml/min/1.73m^2 (as per the CKD-EPI equation);
- BMI ≤45kg/m^2;
- Blood pressure ≤160/90 and ≥90/60 at screening.
Who cannot join
- Diagnosis of type 1 diabetes;
- Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain);
- Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening;
- Prior episode of graft pyelonephritis in the 1 month prior to screening;
- Episode of acute graft rejection in the 3 months prior to screening;
- Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening;
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- Untreated urinary or genital tract infection;
- Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness;
- Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;
- Participation in another trial with an investigational drug within 30 days of informed consent;
- Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation;
- Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement.
- Patients currently using antipsychotic medications.
- Use of SGLT2 inhibitors within 1 month of starting the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients: The INFINITI Study
This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM). The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.
Read the detailed description
Kidney transplantation is the renal replacement therapy of choice for patients with end stage renal disease (ESRD). It has been well established that kidney transplantation improves patient survival and quality of life, and results in significant savings to the health care system.
Despite the survival benefit conferred by transplantation, KTR still face a number of challenges, especially in patients with diabetes. First, KTR still have a higher risk of mortality than their age-matched counterparts without kidney disease. This mortality risk is even greater amongst KTR with diabetes. Furthermore, mortality from cardiovascular disease (CVD) continues to be an important problem after transplantation. Another major challenge faced by KTR is the continuing risk of developing graft failure over time. Unfortunately, in the subgroup of KTR with diabetes, the incidence of graft failure is 50% higher than the general kidney transplant recipient population, and recurrent diabetic kidney disease (DKD) occurs in almost half of allografts after transplantation. Current strategies in the management of graft dysfunction and chronic kidney disease (CKD) are focused on optimizing immunosuppression and control of hypertension and dyslipidemia. Accordingly, there is an important unmet need for cardio- and renoprotective strategies to address premature death and graft loss in the KTR population.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are glucose lowering agents that are effective in the treatment of T2D, resulting not only in improved glycemic control, but also weight loss, blood pressure and albuminuria reduction. Several clinical trials have shown significant benefits of SGLT2i on cardiovascular and renal outcomes. Given the glucose-dependent and independent effects of SGLT2i, as well as the accumulating evidence demonstrating cardiorenal protection in non-KTR, the use of these agents in KTR is attractive - especially since traditional renin-angiotensin-aldosterone system inhibitors are not effective. Moreover, the use of SGLT2i as a cardiorenal protective therapy may be of particular value in KTR given the high burden of comorbidities such as diabetes, CVD and hypertension, as well as the ongoing challenges of premature death and graft loss in this population.
This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 KTR with or without pre-existing T2D or PTDM. The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR. The secondary outcomes of this study include metabolic, vascular, renal and transplant-specific measures. These outcomes have been included to elucidate the potential mechanisms responsible for blood pressure lowering, and putative cardio- and renoprotective effects in KTR. Safety outcomes will also be assessed.
- Being tested
- Dapagliflozin 10 MG Oral Tablet, Placebo Matching Dapagliflozin Oral Tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG Oral TabletDrug
Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.
Placebo Matching Dapagliflozin Oral TabletDrug
Placebo will be administered for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Tablets | Experimental | Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Receives: Drug: Dapagliflozin 10 MG Oral Tablet |
| Placebo Matching Dapagliflozin Tablets | Placebo comparator | Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Receives: Drug: Placebo Matching Dapagliflozin Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SBP)
SBP
Measured: Change from baseline SBP at 12 weeks of treatment
Secondary outcomes (8)
Fasting Plasma Glucose
Fasting plasma glucose
Measured: Change from baseline fasting plasma glucose at 12 weeks of treatment
Glycated Hemoglobin (HbA1c)
HbA1c
Measured: Change from baseline HbA1c at 12 weeks of treatment
Carotid-femoral Pulse Wave Velocity
Measured using a Sphygmocor device
Measured: Change from baseline arterial stiffness at 12 weeks of treatment
Systemic Vascular Resistance
Measured using non-invasive cardiac output monitor (NICOM)
Measured: Change from baseline systemic vascular resistance at 12 weeks of treatment
Measured GFR
GFR
Measured: Change from baseline GFR (based on plasma iohexol clearance) at 12 weeks of treatment
Proximal Tubular Natriuresis
Measured by fractional excretion of exogenous lithium (FELi)
Measured: Change from baseline proximal tubular natriuresis at 12 weeks of treatment
UACR
Albuminuria
Measured: Change from baseline albuminuria at 12 weeks of treatment
Weight
Weight
Measured: Change from baseline weight at 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start15 Jul 2021
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be allocated to receive either 10 mg daily of dapagliflozin or a matching placebo for 12 weeks in a 1:1 ratio while continuing on existing medical therapy for glycemic control as recommended by Diabetes Canada.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunita Singh, MD, MSc, FRCPC, University Health Network, Toronto
- Investigators
- Sunita KS Singh, MD MSc FRCPC, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965935
- Sponsor's protocol ID
- 19-5342
- Acronym
- INFINITI2019
- Status last verified
- Apr 2026
- First submitted
- 21 May 2021
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sridhar VS, Kugathasan L, Lytvyn Y, Liu H, Deng Y, Lovblom LE, Nardone M, Yuen DA, Chen Y, Hua J, Aronson Y, Mohsen M, Kim SJ, Udell JA, Perkins BA, Stevens J, Touw DJ, Heerspink HJL, Cherney DZI, Singh SKS. Efficacy, Mechanisms, and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Kidney Transplant Recipients: A Randomized, Double-Blind, Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):664-679. doi: 10.2215/CJN.0000000951. Epub 2025 Dec 12.
PubMed 41385300