| Trial ID: | L1104 |
| Source ID: | NCT00204230
|
| Associated Drug: |
Mycophenolate Mofetil (Drug)
|
| Title: |
MMF and Calcineurin Inhibitor Withdrawal in CAN
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Immunosuppressive Agents|Kidney Failure, Chronic|Kidney Transplantation
|
| Interventions: |
DRUG: mycophenolate mofetil (drug)
|
| Outcome Measures: |
Primary: course of renal function over 35 weeks | Secondary: after 35 weeks of follow up:|incidence of|-acute rejections|-infections|-malignomas|-gastrointestinal disorders|development of blood pressure over 35 weeks|number of antihypertensive drugs|lipid state at entry and after 35 weeks|blood glucose ,HBA1c at entry and after 35 weeks|uric acid at entry and after 35 weeks|Comparison of the development of 1/creatinine within each group at entry and 35 weeks after therapy conversion|area under the curve (AUC) determination of mycophenolic acid (MPA)|vessel wall changes of the carotid arteries IMD , compliance, distensibility and hemodynamic parameters CO, CI, at entry and after after cni withdrawal and MMF addition
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Muenster | Collaborators: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
86
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
1999-10
|
| Completion Date: |
2002-09
|
| Results First Posted: |
|
| Last Update Posted: |
2005-09-20
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00204230
|
