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Last Updated: May 26, 2020

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CLINICAL TRIALS PROFILE FOR ENVARSUS XR

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All Clinical Trials for Envarsus Xr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02339246 Pharmacokinetic Comparison Of All FK-506 Formulations Completed Veloxis Pharmaceuticals Phase 3 2015-01-01 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 1969-12-31 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 2015-05-01 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 2015-07-01 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.
NCT02882828 PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) Not yet recruiting University Hospital, Limoges Phase 4 2016-10-01 Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert system and made them available to the transplant community through our very successful ISBA (Immunosuppressive drugs Bayesian dose Adjustment) website. Briefly, we first need to develop a population pharmacokinetic model using rich pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The model developed can then be used for inference of ISD PK parameters in new patients using Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK parameters are estimated based on the known PK parameters in the population (mean and distribution), given the dose and concentrations observed in a patient. Our previous studies have shown that a limited sampling strategy (LSS) based on 3 samples collected within the first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the present study, the AUC0-24h and the recommended dose will be calculated using Bayesian estimators previously developed using PK data from the clinical trials run by Veloxis, and proposed to the clinicians via a dedicated website comparable with ISBA.
>Trial ID >Title >Status >Phase >Start Date >Summary

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 22
France 2
Italy 1
Poland 1
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Trials by US State

Trials by US State for Envarsus Xr
Location Trials
California 4
Ohio 2
Minnesota 2
New York 1
District of Columbia 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 17
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 19
Recruiting 7
Completed 2
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Clinical Trial Sponsors for Envarsus Xr

Sponsor Name

Sponsor Name for Envarsus Xr
Sponsor Trials
Veloxis Pharmaceuticals 14
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 36
Industry 18
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