| Trial ID: | L0964 |
| Source ID: | NCT00374803
|
| Associated Drug: |
Mycophenolic Acid (Myfortic)
|
| Title: |
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00374803/results
|
| Conditions: |
End Stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: Mycophenolic Acid (Myfortic)
|
| Outcome Measures: |
Primary: Incidence of All Biopsy Proven Acute Rejection., Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine, 12 months | Secondary: Patient and Allograft Survival 12 Months, Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival., 12 months|Renal Function at 12 Months, Renal function measured by serum creatinine (SCr) at 12 months post-transplant, 12 months|Incidence of Post Transplant Infections, Incidence of post transplant infections that resulted in hospitalization, 12 months|GI Toxicities, Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic), 12 months
|
| Sponsor/Collaborators: |
Sponsor: University of Cincinnati | Collaborators: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
2008-01
|
| Results First Posted: |
2012-05-08
|
| Last Update Posted: |
2016-04-28
|
| Locations: |
The Christ Hospital, Cincinnati, Ohio, 45267, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00374803
|
