Immune Development in Pediatric Transplantation (IMPACT)

Completed

Conditions studied: Chronic Kidney Failure, End Stage Renal Disease

In brief

Transplantation is the preferred method of treatment for end-stage renal disease (ESRD) in children. Over the past forty years, the use of newer immunosuppressive drugs has decreased the risk for organ rejection considerably, and improved short-term outcomes. However, these costly and complicated life-long treatment regimens also cause serious side effects. This has been particularly true for children, who undergo treatment with these drugs at the same time they are transitioning, physically and emotionally, from childhood to adulthood. These factors lead to significantly reduced life-spans, decreased drug regimen adherence, and an increased need for re-transplantation, as compared with adults. Current immunosuppressive procedures and strategies for children mimic those for adults, despite the difference between the two populations' immune systems and needs. New strategies aimed at tailoring to an individual child's needs would both reduce the risk of complications and improve outcomes. The purpose of this study is to generate information which will help to change the current practice of pediatric transplantation into one that is more individualized and preventative.

Key facts

Study ID

NCT00951353

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

125

Starts

2009-07-01

Expected to finish

2013-03-01

Last updated by the study team

2019-01-03

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent or legal guardian willing to provide informed consent, if necessary
• 1 to 20 years of age (before 21st birthday) at the time of enrollment
• Undergoing renal transplantation

You may not qualify if…

• Need for multi-organ transplantation
• Any prior history of organ transplantation
• Inability or unwillingness of participant of their legal guardian to give written informed consent or comply with study protocol

Where it is running

• University of California at Los Angeles/ Mattel Children's Hospital — Los Angeles, California, United States
• Stanford University Medical Center/ Lucille Packard Children's Hospital — Palo Alto, California, United States
• Emory University/ Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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