| Trial ID: | L0946 |
| Source ID: | NCT00533624
|
| Associated Drug: |
Mycophenolate Sodium Delayed Release Tablets
|
| Title: |
Myfortic vs. Cellcept in Kidney Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Mycophenolate Sodium Delayed Release Tablets|DRUG: Mycophenolate Mofetil
|
| Outcome Measures: |
Primary: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra)., 1 year | Secondary: Incidence of AE: Infections, malignancies (including PTLD), thromboembolic events, hyperlipidemia and leuko and thrombocytopenia, cytokine release syndrome with induction antibody agents, wound healing and lymphocele, post-tx diabetes., 1 year
|
| Sponsor/Collaborators: |
Sponsor: University of Miami | Collaborators: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-12
|
| Completion Date: |
2006-02
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-28
|
| Locations: |
University of Miami Miller School of Medicine, Miami, Florida, 33136, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00533624
|
