|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 November 2016 |
|
Main ID: |
NCT00149942 |
|
Date of registration:
|
06/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
|
|
Scientific title:
|
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy |
|
Date of first enrolment:
|
October 2004 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00149942 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Novartis |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower
gastro-intestinal adverse events
Exclusion Criteria:
- Recent graft rejection before the study
- Other pre-existing conditions that may cause gastro-intestinal complaints
- Use of other drugs known to cause gastro-intestinal complaints
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Kidney Transplantation
|
|
Liver Transplantation
|
|
Intervention(s)
|
|
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
|
|
Primary Outcome(s)
|
|
Gastro-intestinal adverse events before switch versus 3 months after switch
|
|
Secondary Outcome(s)
|
|
Severity of biopsy-proven rejections after conversion.
|
|
Proportion of patients who had graft loss after conversion.
|
|
Frequency of adverse events
|
|
Frequency of infections
|
|
Time to the first biopsy-proven rejection after conversion.
|
|
Secondary ID(s)
|
|
CERL080ABE01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|