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Generated: December 10, 2018

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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.
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 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.
NCT02954198 Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients Not yet recruiting Medical University of South Carolina N/A With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.
NCT02956005 Envarsus XR in African American Renal Transplant Recipients Recruiting Georgetown University N/A The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR. African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies. The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Envarsus Xr

Condition Name

Condition Name for Envarsus Xr
Intervention Trials
Kidney Transplant Failure and Rejection 4
Kidney Transplant; Complications 4
End Stage Renal Disease 3
Immunosuppression 2
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Condition MeSH

Condition MeSH for Envarsus Xr
Intervention Trials
Kidney Failure, Chronic 3
Renal Insufficiency 2
Neurotoxicity Syndromes 1
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 13
France 2
Poland 1
Italy 1
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Trials by US State

Trials by US State for Envarsus Xr
Location Trials
California 3
Illinois 1
Colorado 1
District of Columbia 1
South Carolina 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 9
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Envarsus Xr
Clinical Trial Phase Trials
Not yet recruiting 8
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 7
Chiesi Farmaceutici S.p.A. 3
Meghan Pearl, MD 1
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Sponsor Type

Sponsor Type for Envarsus Xr
Sponsor Trials
Other 17
Industry 11
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Army
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