| Trial ID: | L0970 |
| Source ID: | NCT00023231
|
| Associated Drug: |
Daclizumab
|
| Title: |
Pediatric Kidney Transplant Without Calcineurin Inhibitors
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease
|
| Interventions: |
DRUG: Daclizumab|DRUG: Methylprednisolone/prednisone|DRUG: Mycophenolate mofetil|DRUG: Sirolimus|DRUG: Bactrim|DRUG: Ganciclovir|DRUG: Lipitor
|
| Outcome Measures: |
Primary: Efficacy of treatment without calcineurin inhibitors, compared to current standard immunosuppressive treatment, Throughout study|Adverse effects of treatment without calcineurin inhibitors, compared to current standard immunosuppressive treatment, especially hypertension, serious infections and chronic nephrotoxicity, Throughout study | Secondary: Immune inhibition detected by sensitive and specific assays (including intragraft and peripheral monitoring) for expression patterns of activation and effector function markers, Throughout study
|
| Sponsor/Collaborators: |
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-02
|
| Completion Date: |
2006-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-21
|
| Locations: |
Lauren Schenker, Rockville, Maryland, 20850, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00023231
|
