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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR MYCOPHENOLIC SODIUM


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All Clinical Trials for Mycophenolic Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00167492 ↗ Enteric Coated Myfortic for Liver Transplant Recipients Withdrawn Novartis Phase 4 2005-09-01 The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation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NCT00167492 ↗ Enteric Coated Myfortic for Liver Transplant Recipients Withdrawn The University of Texas Health Science Center, Houston Phase 4 2005-09-01 The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is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.
NCT00369278 ↗ Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients Completed Novartis Pharmaceuticals Phase 3 2006-06-01 This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).
NCT00400647 ↗ Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil Completed Novartis Phase 4 2006-07-01 This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS). Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mycophenolic Sodium

Condition Name

Condition Name for Mycophenolic Sodium
Intervention Trials
Kidney Transplantation 4
Hyperglycemia 2
Renal Transplantation 2
Kidney Transplant Recipients 2
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Condition MeSH

Condition MeSH for Mycophenolic Sodium
Intervention Trials
Hyperglycemia 2
Keratoconjunctivitis Sicca 1
Fibrosis 1
End Stage Liver Disease 1
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Clinical Trial Locations for Mycophenolic Sodium

Trials by Country

Trials by Country for Mycophenolic Sodium
Location Trials
United States 28
Germany 5
Canada 2
Brazil 1
Austria 1
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Trials by US State

Trials by US State for Mycophenolic Sodium
Location Trials
Texas 3
Illinois 2
Georgia 2
Florida 2
California 2
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Clinical Trial Progress for Mycophenolic Sodium

Clinical Trial Phase

Clinical Trial Phase for Mycophenolic Sodium
Clinical Trial Phase Trials
Phase 4 9
Phase 3 5
Phase 2 1
[disabled in preview] 3
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Clinical Trial Status

Clinical Trial Status for Mycophenolic Sodium
Clinical Trial Phase Trials
Completed 13
Withdrawn 2
Not yet recruiting 2
[disabled in preview] 2
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Clinical Trial Sponsors for Mycophenolic Sodium

Sponsor Name

Sponsor Name for Mycophenolic Sodium
Sponsor Trials
Novartis 6
Novartis Pharmaceuticals 3
Medical University of Vienna 2
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Sponsor Type

Sponsor Type for Mycophenolic Sodium
Sponsor Trials
Other 18
Industry 13
NIH 2
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