Clinical Trial Details
| Trial ID: | L0978 |
| Source ID: | NCT00023244 |
| Associated Drug: | Basiliximab |
| Title: | Steroid Withdrawal in Pediatric Kidney Transplant Recipients |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | End-Stage Renal Disease |
| Interventions: | DRUG: Basiliximab|DRUG: Cyclosporine|DRUG: Tacrolimus|DRUG: Sirolimus|DRUG: Methylprednisolone|DRUG: Prednisone|DRUG: Bactrim |
| Outcome Measures: | Primary: Growth, measured as change in standardized height from 6 month to 2.5 years post-transplantation, At 6 months and 2.5 years post-transplant | Secondary: Graft and patient survival, Throughout study|Biopsy-proven acute rejection, Throughout study|Renal function, measured by serum creatinine and the calculated creatinine clearances, Throughout study|Hypertension, Throughout study|Cushingoid features, Throughout study|Systolic and diastolic blood pressure levels, Throughout study|Fasting lipid profile, Throughout study |
| Sponsor/Collaborators: | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Collaborators: Cooperative Clinical Trials in Pediatric Transplantation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 274 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2001-01 |
| Completion Date: | 2005-06 |
| Results First Posted: | |
| Last Update Posted: | 2016-10-21 |
| Locations: | University of Alabama, Birmingham, Alabama, 35233, United States|UCSD Medical Center, San Diego, California, 92103, United States|Denver Children's Hospital, Aurora, Colorado, 80045, United States|University of Florida Health Science Center, Jacksonville, Florida, 32209, United States|Emory Children's Center, Atlanta, Georgia, 30322, United States|Tulane University Medical Center, New Orleans, Louisiana, 70112, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Children's Hospital of Boston, Boston, Massachusetts, 02115, United States|University of New Mexico Health Science Center, Albuquerque, New Mexico, 87131, United States|The Children's Hospital of Buffalo, Buffalo, New York, 14222, United States|Westchester Medical Center, Valhalla, New York, 10595, United States|Rainbow Babies and Childrens Hospital, Cleveland, Ohio, 44106, United States|University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States|Penn State College of Medicine, Hershey, Pennsylvania, 17033, United States|LeBonheur Children's Medical Center, Memphis, Tennessee, 38103, United States|Christopher Goldsbury Center, San Antonio, Texas, 78207, United States|Children's Hospital and Regional Medical Center, Seattle, Washington, 98105, United States|University of Wisconsin, Madison, Wisconsin, 53705, United States|Hospital Infantil de Mexico, Mexico City, Distrito Federal, 06720, Mexico |
| URL: | https://clinicaltrials.gov/show/NCT00023244 |
