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SGLT2 Inhibitor

SGLT2 Inhibitor for Kidney Transplant Recipients with Diabetes (INFINITI2019 Trial)

Phase 3
Recruiting
Led By Sunita KS Singh, MD MSc FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In patients with T2D or PTDM, HbA1c <12.0%
Male or females >18 years old ≥ 6months after kidney transplantation
Must not have
Diagnosis of type 1 diabetes
Patients currently using antipsychotic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline proximal tubular natriuresis at 12 weeks of treatment
Awards & highlights

Summary

This trial will compare the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients with diabetes. The primary outcome is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.

Who is the study for?
This trial is for kidney transplant recipients over 18, with or without type 2 diabetes, who are at least six months post-transplant. They should have a stable graft function (eGFR ≥30), controlled blood pressure and HbA1c <12.0%. Exclusions include severe vascular disease, recent acute rejection or cardiovascular events, use of SGLT2 inhibitors within the last month, untreated infections, and certain medication uses.
What is being tested?
The study tests if Dapagliflozin can better reduce blood pressure compared to a placebo in kidney transplant recipients. It's randomized and double-blind meaning neither participants nor researchers know who gets the real drug versus placebo during the trial.
What are the potential side effects?
Potential side effects of Dapagliflozin may include yeast infections due to sugar in urine, urination issues, dehydration risks leading to low blood pressure, possible kidney harm or increased cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HbA1c level is below 12.0%.
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I am over 18 and had a kidney transplant more than 6 months ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with type 1 diabetes.
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I am currently taking antipsychotic medications.
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I have severe issues with my blood vessels, like amputation or non-healing wounds.
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I haven't started or stopped any immune-weakening drugs in the last month.
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I currently have an untreated infection in my urinary or genital area.
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I am a pre-menopausal woman not using birth control and am pregnant, nursing, or could become pregnant.
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I have had a severe low blood sugar episode or didn't notice my low blood sugar levels in the last 3 months.
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I have not taken SGLT2 inhibitors in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline tubulointerstitial hypoxia at 12 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline tubulointerstitial hypoxia at 12 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Systolic blood pressure
Secondary study objectives
Adverse Events (AEs)
Albuminuria
Arterial stiffness
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dapagliflozin TabletsExperimental Treatment1 Intervention
Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks.
Group II: Placebo Matching Dapagliflozin TabletsPlacebo Group1 Intervention
Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10 MG Oral Tablet
2020
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,153 Total Patients Enrolled
Sunita KS Singh, MD MSc FRCPCPrincipal InvestigatorUniversity Health Network, Toronto General Hospital
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Dapagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04965935 — Phase 3
Type 2 Diabetes Research Study Groups: Dapagliflozin Tablets, Placebo Matching Dapagliflozin Tablets
~12 spots leftby Sep 2025
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