ENVARSUS®

DRUG4 trials

Sponsors

Chiesi Farmaceutici S.p.A., Georgetown University, University Hospital, Essen

Conditions

End Stage Renal DiseaseOrgan or Tissue Transplant; ComplicationsPediatric Kidney DiseaseRenal Transplant Recipients

Phase 3

Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation

University Hospital, EssenPediatric Kidney Disease

Start: 2023-04-25End: 2025-03-31Target: 30Updated: 2023-09-28

Phase 4

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

CompletedNCT02432833

Chiesi Farmaceutici S.p.A.End Stage Renal Disease

Start: 2015-05-31End: 2017-01-24Updated: 2018-04-13

Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

CompletedNCT02500212

Chiesi Farmaceutici S.p.A.Organ or Tissue Transplant; Complications

Start: 2015-07-31End: 2016-06-30Updated: 2020-07-31

Unknown Phase

Envarsus XR in African American Renal Transplant Recipients

TerminatedNCT02956005

Georgetown UniversityRenal Transplant Recipients

Start: 2016-09-30End: 2018-09-30Updated: 2020-03-24

Related Papers

A multi-center interventional study to assess pharmacokinetics, effectiveness, and tolerability of prolonged-release tacrolimus after pediatric kidney transplantation: study protocol for a prospective, open-label, randomized, two-phase, two-sequence, single dose, crossover, phase III b trial

Frontiers in Nephrology2024-02-20

Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus in de novo Kidney Transplant Patients Across Europe

Transplant International2022-03-2114 citations

Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study.

2018-12-1431 citations