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Immunosuppressant
Envarsus XR for Delayed Graft Function (E-DGF Trial)
Phase 4
Waitlist Available
Led By Sandesh Paranjuli, MBBS
Research Sponsored by University of Wisconsin, Madison
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 up to 3 months post transplant
Awards & highlights
E-DGF Trial Summary
This trial is testing a new extended release tacrolimus designed to deliver the drug more consistently and avoid large fluctuations in tacrolimus levels. It is expected that patients who receive Envarsus XR will have more stable tacrolimus levels and recover from DGF more quickly than those who receive immediate release tacrolimus.
E-DGF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Days Needed to Recover From Delayed Graft Function (DGF)
Secondary outcome measures
Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF
Other outcome measures
Number of Participants Experiencing Related Adverse Events
E-DGF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Envarsus XR
Group II: Standard of CareActive Control1 Intervention
Standard of Care Tacrolimus
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Envarsus XR
2017
Completed Phase 4
~230
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,184 Previous Clinical Trials
3,169,368 Total Patients Enrolled
3 Trials studying Delayed Graft Function
201 Patients Enrolled for Delayed Graft Function
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,046 Total Patients Enrolled
Sandesh Paranjuli, MBBSPrincipal InvestigatorUniversity of Wisconsin School of Medicine and Public Health, Madison
Frequently Asked Questions
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