Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
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ClinicalTrials.gov Identifier: NCT00239083 |
Recruitment Status
:
Completed
First Posted
: October 14, 2005
Last Update Posted
: February 23, 2017
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Sponsor:
Novartis
Information provided by:
Novartis
Tracking Information | ||||
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First Submitted Date ICMJE | October 12, 2005 | |||
First Posted Date ICMJE | October 14, 2005 | |||
Last Update Posted Date | February 23, 2017 | |||
Study Start Date ICMJE | January 2005 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00239083 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used. | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients | |||
Official Title ICMJE | Phase IV Study of Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Kidney Transplant Patients | |||
Brief Summary | The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Kidney Transplantation | |||
Intervention ICMJE | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) | |||
Study Arms | Experimental: EC-MPS
Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
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Publications * | Nart A, Sipahi S, Aykas A, Uslu A, Hoşcoşkun C, Toz H. Efficacy and safety of enteric-coated mycophenolate sodium in de novo and maintenance renal transplant patients. Transplant Proc. 2008 Jan-Feb;40(1):189-92. doi: 10.1016/j.transproceed.2007.11.066. | |||
* 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 | |||
Estimated Enrollment ICMJE |
40 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | August 2006 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | De Novo-Inclusion criteria
Maintenance-Inclusion criteria
De Novo and Maintenance-Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | 6 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | Not Provided | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00239083 | |||
Other Study ID Numbers ICMJE | CERL080ATR01 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis | |||
Study Sponsor ICMJE | Novartis | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |