Steroid Withdrawal in Pediatric Kidney Transplant Recipients

Stopped early · Phase 2

Conditions studied: End-Stage Renal Disease

In brief

The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.

Key facts

Study ID

NCT00023244

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

274

Starts

2001-01-01

Expected to finish

2005-06-01

Last updated by the study team

2016-10-21

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are between the ages of 0 and 20 years (prior to their 21st birthday)
• Are receiving their first living related (e.g.,kidney from a relative or unrelated donor) or cadaver donor transplant
• Are willing to practice an acceptable method of birth control during the study, if women able to have children

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have received multiple organs
• Have received 2 or more transplants
• Have an active infection (including tuberculosis), or cancer
• Have used an experimental agent within 4 weeks of transplantation

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• UCSD Medical Center — San Diego, California, United States
• Denver Children's Hospital — Aurora, Colorado, United States
• University of Florida Health Science Center — Jacksonville, Florida, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Children's Hospital of Boston — Boston, Massachusetts, United States
• University of New Mexico Health Science Center — Albuquerque, New Mexico, United States
• The Children's Hospital of Buffalo — Buffalo, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• LeBonheur Children's Medical Center — Memphis, Tennessee, United States
• Christopher Goldsbury Center — San Antonio, Texas, United States
• Children's Hospital and Regional Medical Center — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Hospital Infantil de Mexico — Mexico City, Mexico City, Mexico

Full record on ClinicalTrials.gov

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