Status:
COMPLETED
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Astellas Pharma Inc
Hoffmann-La Roche
Conditions:
Kidney Diseases
Kidney Transplantation
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
PHASE2
Brief Summary
Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ...
Detailed Description
Corticosteroids (steroids) have been a cornerstone of immunosuppressive therapy for kidney (renal) transplantation for over 40 years. However, poor growth and bone loss caused by the use of steroids a...
Eligibility Criteria
Inclusion
- Primary recipient of a kidney transplant
- Meets site-specific transplant criteria
- Panel Reactive Antibody (PRA) of 20% or less
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Exclusion
- Previous treatment with steroids within 6 months prior to transplantation
- Received en-bloc kidney or other kidney that does not meet protocol-specified requirements
- Received an organ from an human leukocyte antigen (HLA) identical donor or a non-heart-beating donor
- Received a solid organ other than a kidney
- Received a bone marrow or hematopoietic stem cell transplant
- Received a repeat kidney transplant
- Currently receiving an investigational pharmacologic or biologic agent
- Human Immunodeficiency virus (HIV) infected or infected with another immunodeficiency virus
- Hypersensitivity to murine products or the study drugs or their formulations
- Inability to measure height accurately
- Pregnant or breastfeeding
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00141037
Start Date
March 1 2004
End Date
November 1 2010
Last Update
November 29 2016
Active Locations (12)
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1
University of Alabama - Pediatric Nephrology
Birmingham, Alabama, United States, 35233
2
Maxine Dunitz Children's Health Center Cedars-Sinai
Los Angeles, California, United States, 90048
3
UCLA - Department of Pediatrics, Division of Nephrology
Los Angeles, California, United States, 90095-1752
4
Stanford University Medical Center, Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304