Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149929
First received: September 6, 2005
Last updated: February 1, 2011
Last verified: February 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 6, 2005 | ||||
| Last Updated Date | February 1, 2011 | ||||
| Start Date ICMJE | December 1999 | ||||
| Primary Completion Date | April 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment. | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00149929 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| 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 | Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301 | ||||
| Official Title ICMJE | Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients | ||||
| Brief Summary | Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Renal Transplant | ||||
| Intervention ICMJE | Drug: Mycophenolate sodium (enteric coated) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 246 | ||||
| Completion Date | April 2003 | ||||
| Primary Completion Date | April 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: -First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301 Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00149929 | ||||
| Other Study ID Numbers ICMJE | CERL080A301E | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Novartis | ||||
| Verification Date | February 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||