Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00149903|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Mycophenolate sodium (enteric coated)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2006|
- Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
- Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
- Other variables of efficacy: chronic rejection, graft loss, death.
- Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149903
|General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij|