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SGLT2 Inhibitor

Dapagliflozin for Vascular Disease

Q: Does the study encompass recruitment of individuals who have surpassed their eightieth year?

Patients aged between 18 and 80 are eligible for enrollment in this clinical trial. There are separate studies available for those under 18, totaling at 26, and patients older than 65, amounting to a total of 285 studies.

Q: What is the total number of participants enrolled in this clinical investigation?

Yes, data available on clinicaltrials.gov indicates that this investigation is currently seeking subjects. The trial was initially listed on February 1st, 2024 and last revised on February 15th, 2024. It aims to recruit a total of 80 patients at one designated site.

Q: What are the potential risks associated with Dapagliflozin usage in individuals?

Based on our assessment at Power, the safety rating for Dapagliflozin is 3 due to its Phase 4 status as an approved therapy.

Phase 4

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 and 12 months

Awards & highlights

Study Summary

"This trial aims to determine if a medication called dapagliflozin, which is known to improve heart and kidney health in non-transplant patients, can also benefit kidney transplant recipients with type

Who is the study for?

This trial is for adult kidney transplant recipients aged 18-80 with stable blood pressure, diabetes management, and immunosuppression. Participants must have received their transplant at least a year ago and have specific levels of kidney function and protein in urine. It's not suitable for those who don't meet these health criteria or can't consent.Check my eligibility

What is being tested?

The study tests if Dapagliflozin, a drug that lowers sugar in the body, improves heart health and kidney function in people who got a new kidney but also have diabetes. Some will get the real medicine while others will take a placebo to compare results.See study design

What are the potential side effects?

Dapagliflozin may cause dehydration, low blood sugar, urinary tract infections, genital yeast infections, increased cholesterol levels, and possibly affect kidney function or bone density.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Albuminuria

Secondary outcome measures

Arterial stiffness

Kidney fibrosis

Kidney morphometry, metabolomics from paired kidney biopsies

+4 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471

20%

Cervicovaginal infection

13%

Urinary tract infections

100%

80%

60%

40%

20%

Study treatment Arm

Dapagliflozin

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DapagliflozinExperimental Treatment1 Intervention

Participants will receive dapagliflozin 10mg daily

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive one placebo tablet daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dapagliflozin 10mg Tab

2022

Completed Phase 4

~970

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,446 Total Patients Enrolled

Frequently Asked Questions

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

Are there currently open spots for participants in this ongoing clinical trial?

"Indeed, information from clinicaltrials.gov indicates that this study is currently seeking volunteers. This trial was initially listed on February 1st, 2024, and the latest update was recorded on February 15th, 2024. The research aims to enroll a total of 80 individuals at one specific site."

Answered by AI

What are the eligibility criteria for participating in this clinical trial?

"The study aims to recruit 80 individuals aged between 18 and 80 with vascular conditions. Eligible participants should meet specific requirements including having a blood pressure reading below <130/80 mm Hg before randomization, capacity to give informed consent, steady immunosuppressive therapy for at least three months prior to the baseline using drugs like tacrolimus, mycophenolate mofetil/mycophenolic acid, and prednisone. Additionally, they must have stable management of hypertension for one month preceding the baseline assessment and consistent diabetes control over three months leading up to the baseline evaluation. To qualify further patients need"

Answered by AI

Does the study encompass recruitment of individuals who have surpassed their eightieth year?

"Patients aged between 18 and 80 are eligible for enrollment in this clinical trial. There are separate studies available for those under 18, totaling at 26, and patients older than 65, amounting to a total of 285 studies."

Answered by AI

What is the total number of participants enrolled in this clinical investigation?

"Yes, data available on clinicaltrials.gov indicates that this investigation is currently seeking subjects. The trial was initially listed on February 1st, 2024 and last revised on February 15th, 2024. It aims to recruit a total of 80 patients at one designated site."

Answered by AI