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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR MYFORTIC

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505(b)(2) Clinical Trials for Myfortic

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00374803 Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed Novartis Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
New Formulation NCT00374803 Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal Completed University of Cincinnati Phase 4 2006-04-01 To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
New Combination NCT03249831 Non-Myeloablative Conditioning Regimen With Haploidentical T-Cell-Depleted Peripheral Blood Transplant for Patients With Severe Sickle Cell Disease Recruiting City of Hope Medical Center Phase 1 2018-01-01 Stem cells are made in the bone marrow, and can circulate the blood stream. These blood forming stem cells are collected from the blood stream (peripheral blood stem cells) or the bone marrow for transplant. Blood stem cell transplants can be used to treat patients with sickle cell disease. In the future it is hoped that transplants may also be used to treat other health conditions like diabetes and auto-immune disease. Transplant is often not an option for patients with other serious medical problems and most patients do not have a full-matched donor. Improving transplant success and reducing transplanted-related complications (like graft versus host disease) might allow more patients to get a transplant from a half-matched (haploidentical) donor (e.g. parent, sibling, and daughter/son). This research transplant is being tested in this Pilot study for the first time and is different from a standard transplant because: 1. Haploidentical donors will be used, and 2. A new combination of drugs that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will removed (depleted) before giving the transplant to the patient. After non-myeloablative conditioning treatment and haploidentical transplant, some of the blood cells in the recipient (patient) will be from the donor (mixed chimerism). Having the right mix of donor to recipient T cells can help improve haploidentical transplant outcomes.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Myfortic

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00101738 Freedom Study: Myfortic in Kidney Transplant Patients Completed Novartis Pharmaceuticals Phase 3 2003-03-01 The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
NCT00149968 Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife) Completed Novartis Phase 4 2005-04-01 The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.
NCT00154310 Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients Completed Novartis Phase 4 2005-06-01 The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Myfortic

Condition Name

Condition Name for Myfortic
Intervention Trials
Kidney Transplantation 18
Renal Transplantation 10
Immunosuppression 5
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Condition MeSH

Condition MeSH for Myfortic
Intervention Trials
Renal Insufficiency 7
Kidney Failure, Chronic 7
Communicable Diseases 5
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Clinical Trial Locations for Myfortic

Trials by Country

Trials by Country for Myfortic
Location Trials
United States 75
Germany 16
Canada 14
France 11
Switzerland 10
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Trials by US State

Trials by US State for Myfortic
Location Trials
California 10
Pennsylvania 8
New York 6
Ohio 6
Florida 6
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Clinical Trial Progress for Myfortic

Clinical Trial Phase

Clinical Trial Phase for Myfortic
Clinical Trial Phase Trials
Phase 4 49
Phase 3 18
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Myfortic
Clinical Trial Phase Trials
Completed 45
Recruiting 17
Terminated 13
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Clinical Trial Sponsors for Myfortic

Sponsor Name

Sponsor Name for Myfortic
Sponsor Trials
Novartis Pharmaceuticals 29
Novartis 28
Astellas Pharma Inc 3
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Sponsor Type

Sponsor Type for Myfortic
Sponsor Trials
Other 88
Industry 74
NIH 5
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