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Generated: September 16, 2019

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CLINICAL TRIALS PROFILE FOR ENVARSUS XR

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Clinical Trials for Envarsus Xr

Trial ID Title Status Sponsor Phase Summary
NCT02339246 Pharmacokinetic Comparison Of All FK-506 Formulations Completed Veloxis Pharmaceuticals Phase 3 The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.
NCT02411604 Expanded Access Study for Renal Transplant Patients With Envarsus XR ™ Approved for marketing Veloxis Pharmaceuticals N/A Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).
NCT02432833 Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients Active, not recruiting Chiesi Farmaceutici S.p.A. Phase 4 The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a real-life setting in different European Countries.
NCT02500212 Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients Completed Chiesi Farmaceutici S.p.A. Phase 4 Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
>Trial ID >Title >Status >Phase >Summary

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Clinical Trial Conditions for Envarsus Xr

Condition Name

Condition Name for Envarsus Xr
Intervention Trials
Kidney Transplant; Complications 5
Kidney Transplant Failure and Rejection 4
Immunosuppression 4
Kidney Transplantation 3
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Condition MeSH

Condition MeSH for Envarsus Xr
Intervention Trials
Kidney Failure, Chronic 3
Renal Insufficiency 3
Neurotoxicity Syndromes 2
Drug-Related Side Effects and Adverse Reactions 1
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Clinical Trial Locations for Envarsus Xr

Trials by Country

Trials by Country for Envarsus Xr
Location Trials
United States 21
France 2
Italy 1
Poland 1
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Trials by US State

Trials by US State for Envarsus Xr
Location Trials
California 3
Ohio 2
Minnesota 2
District of Columbia 1
Tennessee 1
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Clinical Trial Progress for Envarsus Xr

Clinical Trial Phase

Clinical Trial Phase for Envarsus Xr
Clinical Trial Phase Trials
Phase 4 16
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Envarsus Xr
Clinical Trial Phase Trials
Not yet recruiting 18
Recruiting 6
Completed 2
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Clinical Trial Sponsors for Envarsus Xr

Sponsor Name

Sponsor Name for Envarsus Xr
Sponsor Trials
Veloxis Pharmaceuticals 13
Chiesi Farmaceutici S.p.A. 3
Medical University of South Carolina 2
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Sponsor Type

Sponsor Type for Envarsus Xr
Sponsor Trials
Other 34
Industry 17
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