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SGLT2 Inhibitor

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

Q: Has Dapagliflozin 10 MG Oral Tablet been federally certified in the United States?

Dapagliflozin 10 MG Oral Tablet is considered safe based on data from prior Phase 3 trials.

Q: What is the typical purpose for taking Dapagliflozin 10 MG Oral Tablet?

Dapagliflozin 10 MG Oral Tablet is most commonly used as part of a treatment regimen for pharmaceutical preparations. This medication can also help patients who are struggling with conditions like <a href="https://www.withpower.com/clinical-trials/diet">diet</a>, exercise, and inadequate response to monotherapy.

Q: Are there any unfilled positions for test subjects in this experiment?

Yes, this is an ongoing clinical trial that is actively recruiting patients, as shown by the most recent update on clinicaltrials.gov from February 7th, 2022.

Q: How many volunteers are helping to test this new medication?

Yes, the data on clinicaltrials.gov indicates that this trial is presently looking for participants. The clinical trial was first posted on 2021-07-15 and was last updated on 2022-02-07. The study is enrolling 52 patients between 1 locations.

Q: Is this a new or innovative clinical study?

As of now, 67 different clinical trials for Dapagliflozin 10 MG Oral Tablet are underway in 236 distinct locations. The first ever trial began back in 2014 and was sponsored by AstraZeneca. In total, 700 patients were involved in the study which completed its N/A drug approval stage. From 2014 to present day, a total of 173 clinical trials have finished.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline proximal tubular natriuresis at 12 weeks of treatment

Awards & highlights

INFINITI2019 Trial 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.Check my eligibility

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.See study design

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.

INFINITI2019 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My HbA1c level is below 12.0%.

Select...

I am over 18 and had a kidney transplant more than 6 months ago.

INFINITI2019 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline tubulointerstitial hypoxia at 12 weeks of treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systolic blood pressure

Secondary outcome measures

Adverse Events (AEs)

Albuminuria

Arterial stiffness

+10 more

INFINITI2019 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,473 Previous Clinical Trials

484,953 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dapagliflozin 10 MG Oral Tablet been federally certified in the United States?

"Dapagliflozin 10 MG Oral Tablet is considered safe based on data from prior Phase 3 trials."

Answered by AI

What is the typical purpose for taking Dapagliflozin 10 MG Oral Tablet?

"Dapagliflozin 10 MG Oral Tablet is most commonly used as part of a treatment regimen for pharmaceutical preparations. This medication can also help patients who are struggling with conditions like diet, exercise, and inadequate response to monotherapy."

Answered by AI

Are there any unfilled positions for test subjects in this experiment?

"Yes, this is an ongoing clinical trial that is actively recruiting patients, as shown by the most recent update on clinicaltrials.gov from February 7th, 2022."

Answered by AI

How many volunteers are helping to test this new medication?

"Yes, the data on clinicaltrials.gov indicates that this trial is presently looking for participants. The clinical trial was first posted on 2021-07-15 and was last updated on 2022-02-07. The study is enrolling 52 patients between 1 locations."

Answered by AI

Is this a new or innovative clinical study?

"As of now, 67 different clinical trials for Dapagliflozin 10 MG Oral Tablet are underway in 236 distinct locations. The first ever trial began back in 2014 and was sponsored by AstraZeneca. In total, 700 patients were involved in the study which completed its N/A drug approval stage. From 2014 to present day, a total of 173 clinical trials have finished."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients

2021. "Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965935.

All > Kidney Transplant