7 completed, 4 unknown, 2 recruiting, 1 active not recruiting. 9 Phase 4, 3 Not applicable, 2 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 9 | Completed 3, Recruiting 2, Unknown 2, Active not recruiting 1, Enrolling by invitation 1 |
| Not applicable | 3 | Completed 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 1 | 1 | Unknown 1 |
Follow Envarsus: new trials by email Literature Review of Envarsus trials Research Report on Envarsus
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs Tacrolimus Pill, Tacrolimus capsule - Immunosuppression | Phase 4 | Recruiting | Edward Geissler | 300 | 2024-03-09 | 2024-05-16 |
| Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients Prograf, Envarsus - Liver Transplant Rejection, Immune System Suppression | Phase 4 | Enrolling by invitation | University Health Network, Toronto | 40 | 2024-01-01 | 2024-12-11 |
| Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations Tacrolimus, Immediate Release, Oral, Tacrolimus Extended Release Oral Tablet - Liver Transplantation, Immunosuppression | Phase 4 | Recruiting | University of British Columbia | 124 | 2023-01-09 | 2024-01-02 |
| ENvarsus for Impaired Glucose Tolerance Post REnal transplAnT Envarsus, Adoport - Renal Transplant Failure | Not applicable | Withdrawn | Barts & The London NHS Trust | 2022-01-31 | 2022-04-01 | |
| Tacrolimus Versus Mycophenolate for Autoimmune Hepatitis Patients With Incomplete Response on First Line Therapy Mycophenolate Mofetil, Tacrolimus - Autoimmune Hepatitis | Phase 4 | Unknown | Leiden University Medical Center | 86 | 2022-01-19 | 2022-02-03 |
| Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients Tacrolimus Pill, Tacrolimus capsule - Prophylaxis Against Liver Transplant Rejection | Phase 4 | Active not recruiting | Edward Geissler | 268 | 2020-12-23 | 2025-04-06 |
| Envarsus Neurotoxicity Burden in Liver Transplant Patients Envarsus, Tacrolimus Immediate release - Neurotoxicity, Liver Transplant; Complications | Phase 4 | Completed | Medical University of South Carolina | 30 | 2020-01-31 | 2025-03-30 |
| Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus Tacrolimus - Transplant;Failure,Kidney | Phase 4 | Completed | Sentara Norfolk General Hospital | 46 | 2020-01-16 | 2024-02-29 |
| Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus Envarsus, Tacrolimus - End Stage Renal Disease | Completed | University of Kansas Medical Center | 30 | 2018-10-25 | 2021-04-27 | |
| Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients Envarsus, Tacrolimus - Kidney Transplant; Complications, Kidney Transplant Failure and Rejection | Phase 1 | Unknown | California Institute of Renal Research | 50 | 2018-07-11 | 2023-02-09 |
| Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial Envarsus, Advagraf - Liver Transplant Rejection, Immunosuppression | Not applicable | Unknown | Medical University of Warsaw | 200 | 2018-07-09 | 2018-07-27 |
| Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients Envarsus, IR Tacrolimus - Kidney Transplant; Complications, Toxicity | Phase 4 | Completed | University of California, Davis | 64 | 2018-04-01 | 2025-04-08 |
| Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen Envarsus - Heart Transplant Rejection, Graft Failure | Phase 2 | Completed | Baylor Research Institute | 50 | 2017-12-04 | 2025-10-08 |
| AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation ENVARSUS, Standard twice daily tacrolimus - Kidney Transplant Failure and Rejection | Phase 4 | Unknown | University Hospital Birmingham NHS Foundation Trust | 40 | 2017-04-01 | 2016-12-29 |
| Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study Tacrolimus, Everolimus - Kidney Transplantation | Phase 2 | Completed | Chiesi Farmaceutici S.p.A. | 28 | 2017-01-01 | 2019-03-01 |
| Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients Tacrolimus, Prednisone, Mycophenolate mofetil - Immunosuppression | Not applicable | Completed | Medical University of South Carolina | 40 | 2016-12-01 | 2019-12-24 |
Neurotoxicity Syndromes (3) · Rejection, Psychology (2) · Drug-Related Side Effects and Adverse Reactions (1) · Hepatitis, Autoimmune (1) · Kidney Failure, Chronic (1) · Patient Compliance (1) · Tremor (1)
Edward Geissler (2) · Medical University of South Carolina (2) · Barts & The London NHS Trust (1) · Baylor Research Institute (1) · California Institute of Renal Research (1) · Chiesi Farmaceutici S.p.A. (1) · Leiden University Medical Center (1) · Medical University of Warsaw (1) · Sentara Norfolk General Hospital (1) · University Health Network, Toronto (1) · University Hospital Birmingham NHS Foundation Trust (1) · University of British Columbia (1) · University of California, Davis (1) · University of Kansas Medical Center (1)
United States (7) · Canada (2) · Germany (2) · Italy (1) · Netherlands (1) · Poland (1) · United Kingdom (1)
Aditi Gupta, MD (1) · Adnan Sharif, MD (1) · Arman Faravardeh, MD (1) · Bart van Hoek (1) · Bernhard Banas, MD (1) · Derek Dubay, MD (1) · Hans J. Schlitt, MD (1) · Jo-Ann Ford, RN (1) · Ling-Xin Chen, MD (1) · Nazia Selzner, MD (1) · Paolo Rigotti, MD (1) · Shelley Hall, MD, FACC, FHFSA (1) · Thomas McCune, MD (1) · Trana Hussaini, Pharm D (1)
PMID 36094829, PMID 37170284, PMID 38233878, PMID 41089174
2015 (1), 2023 (1)