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Last Updated: May 11, 2021

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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.
NCT00167492 Enteric Coated Myfortic for Liver Transplant Recipients Withdrawn Novartis Phase 4 2005-09-01 The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
NCT00167492 Enteric Coated Myfortic for Liver Transplant Recipients Withdrawn The University of Texas Health Science Center, Houston Phase 4 2005-09-01 The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.
NCT00251004 Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients Completed Novartis Phase 3 2005-10-01 The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
NCT00267150 Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants Completed Novartis Pharmaceuticals Phase 3 2005-11-01 Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Myfortic

Condition Name

Condition Name for Myfortic
Intervention Trials
Kidney Transplantation 19
Renal Transplantation 10
Immunosuppression 5
Liver Transplantation 4
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Condition MeSH

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

Trials by Country

Trials by Country for Myfortic
Location Trials
United States 76
Germany 16
Canada 14
France 12
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 50
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
University of Wisconsin, Madison 3
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Sponsor Type

Sponsor Type for Myfortic
Sponsor Trials
Other 89
Industry 75
NIH 5
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