| Trial ID: | L0986 |
| Source ID: | NCT00768729
|
| Associated Drug: |
Sirolimus
|
| Title: |
Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|Kidney Transplantation|Immunosuppression
|
| Interventions: |
DRUG: Sirolimus|DRUG: MMF or Azathioprine
|
| Outcome Measures: |
Primary: Per-person incidence of acute rejection episodes and death or graft loss, Throughout study | Secondary: Incidence of chronic allograft dysfunction, Throughout study|Incidence of sub-clinical rejection, Throughout study|Incidence of hospitalizations, Throughout study|Incidence of surgical complications, Throughout study|Resumption of MMF or other therapy, Throughout study|Incidence, severity, and treatment of anemia, hypertension, hyperlipidemia, proteinuria, thrombocytopenia, and leukopenia, Throughout study|Incidence, severity, and treatment of opportunistic infections, Throughout study|Incidence of biopsy proven PTLD, Throughout study|Renal function assessed by measured GFR, At baseline, week 48 and week 96|Development of donor-specific or non-specific anti-HLA antibodies, Throughout study|Evolution of immune response in cellular, humoral, and molecular assays from baseline through week 96, Throughout study
|
| Sponsor/Collaborators: |
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2009-05
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-15
|
| Locations: |
Children's Hospital of Central California, Madera, California, United States|UCSF Children's Hospital, San Francisco, California, United States|Children's Hospital, Boston, Boston, Massachusetts, United States|Children's Hospital, Philadelphia, Philadelphia, Pennsylvania, United States|Children's Hospital and Regional Medical Center, Seattle, Seattle, Washington, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00768729
|
