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SGLT2 Inhibitor

Dapagliflozin for Kidney Complications

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
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Albuminuria
Secondary study objectives
Arterial stiffness
Kidney fibrosis
Kidney morphometry, metabolomics from paired kidney biopsies
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~1070

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,797 Total Patients Enrolled
~53 spots leftby Oct 2028
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