6 completed, 2 recruiting, 1 active not recruiting. 9 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 6, Recruiting 2, Active not recruiting 1 |
| Phase 2 | 4 | Recruiting 2, Active not recruiting 1, Completed 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 |
|---|---|---|---|---|---|---|
| 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 |
| CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients Envarsus XR - Kidney Pancreas Transplantation | Phase 2 / Phase 3 | Recruiting | University of Wisconsin, Madison | 20 | 2019-02-27 | 2026-10-29 |
| Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant EnvarsusXR, Tacrolimus - Post Liver Transplant | Phase 2 / Phase 3 | Active not recruiting | Albert Einstein Healthcare Network | 35 | 2017-12-13 | 2021-01-08 |
| Pharmacokinetic Comparison Of All FK-506 Formulations Prograf vs Envarsus XR vs Astagraf XL, Prograf vs Astagraf XL vs Envarsus XR - Renal Failure | Phase 3 | Completed | Veloxis Pharmaceuticals | 32 | 2015-01-01 | 2016-01-18 |
| Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily. LCP-Tacro, Tacrolimus -IR - Renal Failure | Phase 3 | Completed | Veloxis Pharmaceuticals | 50 | 2013-11-01 | 2018-06-06 |
| Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO) Prograf, LCP-Tacro - Renal Failure, Tremors | Phase 3 | Completed | Veloxis Pharmaceuticals | 44 | 2011-12-01 | 2015-10-01 |
| Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx Prograf (tacrolimus), LCP-Tacro - Renal Failure | Phase 3 | Completed | Veloxis Pharmaceuticals | 543 | 2010-09-01 | 2016-05-18 |
| Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily LCP-Tacro, Prograf - Renal Failure | Phase 3 | Completed | Veloxis Pharmaceuticals | 326 | 2008-12-01 | 2015-09-10 |
| 12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia LCP-AtorFen - Dyslipidemia | Phase 2 / Phase 3 | Completed | Veloxis Pharmaceuticals | 140 | 2007-10-01 | 2020-03-24 |
Renal Insufficiency (5) · Tremor (2) · Dyslipidemias (1) · Kidney Failure, Chronic (1)
Tacrolimus (8) · Atorvastatin (1) · Immunosuppression Therapy (1) · Standard of Care (1)
United States (9) · Argentina (1) · Australia (1) · Brazil (1) · France (1) · Germany (1) · Italy (1) · Mexico (1) · New Zealand (1) · Poland (1) · Serbia (1) · Singapore (1) · South Korea (1) · Spain (1) · Sweden (1)
Alan Glicklich (1) · Alan Glicklich, MD (1) · Chivers Woodruff, Jr, MD (1) · Cynthia Strout, MD (1) · Dennis McCluskey, MD (1) · Eduardo Cuevas, MD (1) · Harry Geisberg, MD (1) · James Zavoral, MD (1) · Jeff Geohas, MD (1) · Jon S Odorico, MD (1) · Leslie Callahan, RN (1) · Linda Murray, MD (1) · Manisha Verma, MBBS, MPH (1) · Mark Kipnes, MD (1) · Michael Noss, MD (1)