25 completed, 5 recruiting, 5 terminated, 4 active not recruiting. 17 Phase 4, 13 Phase 2, 9 Phase 3, 3 Early Phase 1, 2 Phase 1.
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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 |
|---|---|---|---|---|---|---|
| VEL-101 to Prevent Rejection After Kidney Transplantation Tacrolimus (TAC), VEL-101 - Transplantation, Kidney | Phase 2 | Recruiting | Veloxis Pharmaceuticals | 120 | 2026-08-18 | 2026-09-03 |
| Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients Conversion to extended-release tacrolimus, Maintenance of immediate-release tacrolimus - Kidney Transplant Recipients, Old Age | Phase 4 | Recruiting | Massachusetts General Hospital | 92 | 2026-03-17 | 2026-05-28 |
| Early Use of Long-acting Tacrolimus in Lung Transplant Recipients Tacrolimus Extended Release Oral Tablet [Envarsus], Tacrolimus, Mycophenolate Mofetil Hydrochloride - Lung Transplant; Complications | Early Phase 1 | Recruiting | Vanderbilt University Medical Center | 48 | 2023-12-01 | 2026-05-15 |
| A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101 VEL-101, Placebo - Healthy Volunteers | Phase 1 | Completed | Veloxis Pharmaceuticals | 60 | 2022-04-26 | 2024-06-27 |
| Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients thrombomodulin alfa, Placebo - Chemotherapy-induced Peripheral Neuropathy | Phase 1 | Terminated | Veloxis Pharmaceuticals | 77 | 2022-03-24 | 2024-08-19 |
| Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR Twice-daily Tacrolimus, Once-daily envarsus XR, Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) - Kidney Transplantation, Kidney Transplant Rejection | Phase 4 | Terminated | University of Southern California | 20 | 2021-11-23 | 2025-11-10 |
| A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo thrombomodulin alfa, Placebo - Chemotherapy-induced Peripheral Neuropathy | Phase 2 | Withdrawn | Veloxis Pharmaceuticals | 2021-10-01 | 2022-02-18 | |
| Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus Conversion from IR Tacrolimus to XR Tacrolimus - Chronic Kidney Diseases, Heart Transplant | Phase 4 | Unknown | Loyola University | 42 | 2021-08-16 | 2022-04-13 |
| Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ Change from Prograf to Envarsus XR - Renal Transplant | Phase 4 | Completed | Vanderbilt University Medical Center | 56 | 2021-06-22 | 2026-04-29 |
| 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 |
| Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients Extended-release tacrolimus, Immediate-release tacrolimus - Kidney Transplant Rejection | Phase 4 | Completed | Cedars-Sinai Medical Center | 20 | 2020-01-09 | 2024-07-10 |
| Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants Extended Release Tacrolimus Tablets, Immediate Release Tacrolimus Capsule - Kidney Transplant; Complications | Phase 4 | Active not recruiting | Roy D. Bloom, MD | 60 | 2019-11-11 | 2026-07-17 |
| Envarsus XR Compared to Immediate Release Tacrolimus Envarsus XR, Tacrolimus twice daily - Kidney Transplant Recipients | Phase 4 | Completed | Mayo Clinic | 261 | 2019-07-18 | 2025-12-18 |
| Veloxis de Novo Kidney Transplant ECSWD Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil, Mycophenolic Acid Oral Product - Kidney Transplantation, Immunosuppression | Phase 4 | Unknown | Simon Tremblay, PharmD, PhD | 60 | 2019-06-21 | 2020-05-13 |
| Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile Tacrolimus, Envarsus XR - End Stage Renal Disease | Phase 2 / Phase 3 | Recruiting | Roberto Gedaly | 78 | 2019-03-28 | 2026-03-24 |
| Envarsus in Delayed Graft Function (E-DGF) Envarsus XR, Tacrolimus - Delayed Graft Function | Phase 4 | Completed | University of Wisconsin, Madison | 100 | 2019-03-18 | 2023-07-20 |
| CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients Envarsus XR - Kidney Pancreas Transplantation | Phase 2 / Phase 3 | Recruiting | University of Wisconsin, Madison | 20 | 2019-02-27 | 2026-04-13 |
| Envarsus XR® in Adolescent Renal Transplant Recipients Envarsus XR, Tacrolimus - Kidney Transplantation, Renal Transplantation | Phase 4 | Active not recruiting | University of California, Los Angeles | 28 | 2019-01-15 | 2023-02-09 |
| Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant - Kidney Transplant | Phase 4 | Completed | Temple University | 36 | 2018-11-12 | 2023-05-11 |
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Renal Insufficiency (9) · Rejection, Psychology (4) · Kidney Failure, Chronic (3) · Tremor (3) · Dyslipidemias (2) · Liver Failure (2) · Neurotoxicity Syndromes (2) · Delayed Graft Function (1) · Drug-Related Side Effects and Adverse Reactions (1) · Hepatitis, Autoimmune (1) · Hepatitis, Chronic (1) · Medication Adherence (1) · Renal Insufficiency, Chronic (1) · Sleep Initiation and Maintenance Disorders (1)
Tacrolimus (33) · Prednisone (4) · Azathioprine (3) · Mycophenolic Acid (3) · ART123 (2) · Atorvastatin (2) · Methylprednisolone (2) · Basiliximab (1) · Fenofibrate (1) · Immunoglobulins, Intravenous (1) · Immunosuppression Therapy (1) · Plasma Exchange (1) · Standard of Care (1) · Steroids (1) · thymoglobulin (1)
United States (40) · Argentina (1) · Australia (1) · Brazil (1) · Canada (1) · France (1) · Germany (1) · Italy (1) · Japan (1) · Mexico (1) · New Zealand (1) · Poland (1) · Serbia (1) · Singapore (1) · South Korea (1)
Rita Alloway, PharmD (3) · Alan Glicklich, MD (2) · Chivers Woodruff, Jr, MD (2) · Cynthia Strout, MD (2) · Dennis McCluskey, MD (2) · Harry Geisberg, MD (2) · James Zavoral, MD (2) · Jeff Geohas, MD (2) · Linda Murray, MD (2) · Mark Kipnes, MD (2) · Michael Noss, MD (2) · Michele Reynolds, MD (2) · Randall Severance, MD (2) · Stephen Halpern, MD (2) · Adam Diamond, PharmD (1)
PMID 36094829, PMID 20110022, PMID 24493215, PMID 27340950, PMID 29162334, PMID 29462506, PMID 30667591, PMID 39158946, PMID 41089174, PMID 42083151