Immune Development in Pediatric Transplantation (IMPACT)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 1 - 20 |
| Updated: | 1/5/2019 |
| Start Date: | July 2009 |
| End Date: | March 2013 |
Immune Development and Alloimmunity in Pediatric Renal Transplant Recipients
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.
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.
Over the past forty years, the use of increasingly effective immunosuppressive drugs has
decreased the risk for organ rejection (acute rejection, AR) considerably, and improved
short-term outcomes. However, these costly and complicated life-long treatment regimens also
cause serious complications in the long-term.
While transplant recipients live significantly longer lives than patients on dialysis,
transplant recipients still have much shorter life spans than their healthy counterparts.
Among reasons for this difference in life-expectancy are the immunosuppressive-drug related
side effects that can lead to complications such as life threatening infections,
malignancies, high blood pressure, heart disease, and diabetes. Additionally, certain drugs
used to prevent organ rejection are known to contribute to renal damage, leading many
patients to experience graft loss within 15 years. To that end, many children undergoing
successful kidney transplantation require re-transplantation as adults. Therefore, while
transplantation yields high success rates in the short-term, the drugs that are responsible
for this early and temporary success are also the cause of later, serious complications. This
is especially true for children, who endure extended drug exposures.
The purpose of this study is to explore the impact of viral exposure on children who receive
immunosuppressive medications after renal transplantation; study the cellular changes
associated with these influences; monitor medication adherence; and observe how all these
factors affect the outcome of kidney transplantation in children. The hope is to better
understand these processes to optimize future transplant therapies for the pediatric
transplant recipient.
This study is designed to observe the immune system response during the first year after
kidney transplant. Cells of the immune system in the recipient's blood, urine, and
transplanted kidney will be tested to observe how the drugs used to prevent rejection
influence them, if these cells change over time, and if they are related to kidney rejection.
The comparisons will allow researchers to study how the developing immune system interacts
with the kidney transplant. Blood from the kidney donor will be requested so that researchers
can study how the recipient's immune system interacts with donor cells.
This study will also look closely at how well participants take prescribed medications. Since
transplant medications are known to change the immune system, tests of the immune system
cells will be compared to tests designed to measure how accurately medications are taken.
Medication adherence will be measured using electronic medication bottle cap records, paper
survey results, and drug levels in the blood. In this way, the study team hopes to learn
about the impact of children's medications on their immune system.
This study will take place at multiple transplant centers in the United States. It is
observational and will involve approximately 75 pediatric renal participants. The study will
last for a total of 3 years, which includes a 2 year accrual period and 12 month follow up.
Clinical treatment will be determined by standard of care at each participating center. There
will be Baseline assessments which will occur before and on the day of transplantation and
follow-up study visits will take place at months 1, 3, 6, 9, and 12 after transplant. Study
assessments and specimens will also be collected at the time of each clinically indicated
biopsy. Study assessments during these follow-up visits will include vital signs; review of
current medications; questions related to adverse events (infection, rejection, graft
failure, malignancy); treatment adherence surveys; and specimen collection for local and
central laboratory testing.
decreased the risk for organ rejection (acute rejection, AR) considerably, and improved
short-term outcomes. However, these costly and complicated life-long treatment regimens also
cause serious complications in the long-term.
While transplant recipients live significantly longer lives than patients on dialysis,
transplant recipients still have much shorter life spans than their healthy counterparts.
Among reasons for this difference in life-expectancy are the immunosuppressive-drug related
side effects that can lead to complications such as life threatening infections,
malignancies, high blood pressure, heart disease, and diabetes. Additionally, certain drugs
used to prevent organ rejection are known to contribute to renal damage, leading many
patients to experience graft loss within 15 years. To that end, many children undergoing
successful kidney transplantation require re-transplantation as adults. Therefore, while
transplantation yields high success rates in the short-term, the drugs that are responsible
for this early and temporary success are also the cause of later, serious complications. This
is especially true for children, who endure extended drug exposures.
The purpose of this study is to explore the impact of viral exposure on children who receive
immunosuppressive medications after renal transplantation; study the cellular changes
associated with these influences; monitor medication adherence; and observe how all these
factors affect the outcome of kidney transplantation in children. The hope is to better
understand these processes to optimize future transplant therapies for the pediatric
transplant recipient.
This study is designed to observe the immune system response during the first year after
kidney transplant. Cells of the immune system in the recipient's blood, urine, and
transplanted kidney will be tested to observe how the drugs used to prevent rejection
influence them, if these cells change over time, and if they are related to kidney rejection.
The comparisons will allow researchers to study how the developing immune system interacts
with the kidney transplant. Blood from the kidney donor will be requested so that researchers
can study how the recipient's immune system interacts with donor cells.
This study will also look closely at how well participants take prescribed medications. Since
transplant medications are known to change the immune system, tests of the immune system
cells will be compared to tests designed to measure how accurately medications are taken.
Medication adherence will be measured using electronic medication bottle cap records, paper
survey results, and drug levels in the blood. In this way, the study team hopes to learn
about the impact of children's medications on their immune system.
This study will take place at multiple transplant centers in the United States. It is
observational and will involve approximately 75 pediatric renal participants. The study will
last for a total of 3 years, which includes a 2 year accrual period and 12 month follow up.
Clinical treatment will be determined by standard of care at each participating center. There
will be Baseline assessments which will occur before and on the day of transplantation and
follow-up study visits will take place at months 1, 3, 6, 9, and 12 after transplant. Study
assessments and specimens will also be collected at the time of each clinically indicated
biopsy. Study assessments during these follow-up visits will include vital signs; review of
current medications; questions related to adverse events (infection, rejection, graft
failure, malignancy); treatment adherence surveys; and specimen collection for local and
central laboratory testing.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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