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SGLT2 Inhibitor

Dapagliflozin for Vascular Disease

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
eGFR 30-90 ml/min/1.73m2
Pre-existing T2D or post-transplant diabetes mellitus
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is between 30 and 90.
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I have type 2 diabetes or diabetes developed after a transplant.
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I have been on a stable dose of immunosuppressants for 3 months.
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My diabetes has been stable for the last 3 months.
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My blood pressure medication has not changed in the last month.
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I am between 18 and 80 years old.
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I received a kidney transplant more than a year ago.

Timeline

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%
0%
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
~950

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,468 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

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."

Answered by AI
~53 spots leftby Oct 2028