CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled / 52 target
Drug / intervention
Dapagliflozin 10 MG Oral Tablet +1 moredrug
Likely dose
Dapagliflozin 10 MG Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04965935
NCT04965935Phase 3CompletedOn Track (0.9/mo)Completion was 22mo ago
CompareCT.gov

Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients: The INFINITI Study

University Health Network, Toronto·interventional·Posted Jul 16, 2021·Updated Jun 8, 2026

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin 10 MG Oral Tablet and Placebo Matching Dapagliflozin Oral Tablet for Kidney Transplant Recipients and 2 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed 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). The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant Recipients, Post-transplant Diabetes Mellitus, Type 2 Diabetes
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 16, 2021
Enrollment StartJul 15, 2021
Primary CompletionAug 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.0 years ago

Arms & Interventions

Dapagliflozin Tabletsexperimental

Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks.

Drug: Dapagliflozin 10 MG Oral Tablet
Placebo Matching Dapagliflozin Tabletsplacebo_comparator

Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks.

Drug: Placebo Matching Dapagliflozin Oral Tablet

Interventions

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.