Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Completed · Phase 1/Phase 2
Conditions studied: Kidney Diseases, Kidney Transplantation, Kidney Transplant, Renal Transplantation, Renal Transplant
In brief
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 transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.
Key facts
- Study ID
- NCT00141037
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 130
- Starts
- 2004-03-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2016-11-29
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama - Pediatric Nephrology — Birmingham, Alabama, United States
- Maxine Dunitz Children's Health Center Cedars-Sinai — Los Angeles, California, United States
- UCLA - Department of Pediatrics, Division of Nephrology — Los Angeles, California, United States
- Stanford University Medical Center, Lucile Packard Children's Hospital — Palo Alto, California, United States
- UCSF Children's Hospital — San Francisco, California, United States
- University of Florida - Pediatric Nephrology — Gainesville, Florida, United States
- Children's Hospital of New Orleans-Department of Pediatric Nephrology — New Orleans, Louisiana, United States
- Children's Hospital Boston - Division of Nephrology — Boston, Massachusetts, United States
- University of Michigan Medical Center, C.S. Mott Children's Hospital- Division of Nephrology & Transplantation — Ann Arbor, Michigan, United States
- Children's Mercy Hospital - Department of Nephrology — Kansas City, Missouri, United States
- The Children's Hospital of Philadelphia-Department of Nephrology — Philadelphia, Pennsylvania, United States
- Children's Hospital & Regional Medical Center - Division of Nephrology — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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