Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
NCT00229138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 291
Last updated 2017-02-07
Summary
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
EC-MPS, Tacrolimus
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-09-30
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- United States
Study Locations
More Related Trials
-
Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
NCT00239070 ·Status: COMPLETED ·Phase: PHASE3
-
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
NCT00239044 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
NCT00537862 ·Status: COMPLETED ·Phase: PHASE4
-
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
NCT00284934 ·Status: COMPLETED ·Phase: PHASE3
-
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
NCT00369278 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
NCT00239018 ·Status: COMPLETED ·Phase: PHASE4
-
Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients
NCT00240955 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
NCT00239083 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
NCT00238992 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
NCT00238966 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)
NCT00154232 ·Status: COMPLETED ·Phase: PHASE4
-
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
NCT00555789 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
NCT00413920 ·Status: COMPLETED ·Phase: PHASE3
-
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
NCT00284921 ·Status: TERMINATED ·Phase: PHASE3
-
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
NCT00171379 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
NCT00239876 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
NCT00171392 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
NCT00154206 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
NCT00492869 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance
NCT00150020 ·Status: COMPLETED ·Phase: PHASE4
-
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
NCT00154245 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
NCT00239057 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients
NCT00170833 ·Status: COMPLETED ·Phase: PHASE3
-
Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
NCT00239811 ·Status: COMPLETED ·Phase: PHASE3