Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
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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: NCT00241059 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : January 31, 2011
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Sponsor:
Novartis
Information provided by:
Novartis
Tracking Information | ||||
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First Submitted Date ICMJE | October 14, 2005 | |||
First Posted Date ICMJE | October 18, 2005 | |||
Last Update Posted Date | January 31, 2011 | |||
Study Start Date ICMJE | August 2002 | |||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety parameters and graft function in maintenance renal transplant recipients. | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients. | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients | |||
Official Title ICMJE | A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients | |||
Brief Summary | The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Renal Transplantation | |||
Intervention ICMJE | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) | |||
Study Arms ICMJE | Experimental: EC-MPS arm
Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
183 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | January 2005 | |||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00241059 | |||
Other Study ID Numbers ICMJE | CERL080A2405LA01E1 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | External Affairs, Novartis Pharmaceticals | |||
Study Sponsor ICMJE | Novartis | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |