Freedom Study: Myfortic in Kidney Transplant Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101738|
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: Myfortic||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||342 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Calculated glomerular filtration rate after 12 months treatment
- Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
- Patient and graft survival after 12 months.
- Incidence of AEs and SAEs after 3 and 12 months.
- Blood pressure, lipids and glucose profiles after 3 and 12 months.
- Percentage of patients free of steroids at 12 months
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): NCT00101738
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