North American Pediatric Renal Transplant Cooperative Study (NAPRTCS)
Seattle Children’s Hopsital is a member of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). This organization tracks and collects the health outcomes of children receiving kidney transplants across North America.
NAPRTCS also sponsors clinical trials that allow transplant centers to complete thorough research to find the best treatments for pediatric kidney transplant patients.
Dr. Ruth McDonald, Seattle Children’s medical director for solid organ transplant, is a member of the NAPRTCS board of directors.
The current goal of the NAPRTCS is to:
- Become a complete end-stage kidney disease patient data system
- Follow patients as they are given end-stage therapies and drugs
- Register and follow more than 80% of children receiving kidney transplants in North America
- Study the clinical course and history of patients with kidney dysfunction
All kidney transplant patients at Seattle Children’s are welcome to participate in NAPRTCS studies.
Many of the studies sponsored by NAPRTCS are funded by the government through the National Institutes of Health (NIH). The NIH has a strong safety monitoring system in place to protect all children who participate.
Families who choose to participate in a NAPRTCS or any other study are free to withdraw their consent at any time and for any reason. Your child will then be treated with Seattle Children’s standard state-of-the-art therapies.
Anti-Rejection Therapy Studies
Seattle Children’s is working with other top transplant centers to improve anti-rejection therapies and quality of life for children after they receive their transplant. Here are three of the studies we are currently involved in with other kidney transplant centers:
This trial tests new anti-rejection medicines that have fewer side effects than those currently used and is open to patients who receive living-donor kidney transplants. The post-transplantation medicine regimen in this trial will not include steroids.
Patients are first given a strong medicine, Campath-1H. After Campath-1H, patients are given a low dose of tacrolimus – currently the anti-rejection medicine of choice – along with another anti-rejection medicine, mycophenolate mofetil.
About two months after transplant, patients are taken off tacrolimus and switched to a protocol of mycophenolate mofetil and the anti-rejection medicine sirolimus.
This protocol avoids both the toxicity of steroids and the long-term toxicity of tacrolimus. The study will assess patient outcomes as well as safety using this combination of anti-rejection medications.
This trial investigates a steroid-free anti-rejection protocol that is now part of a large nationwide multicenter trial. This trial compares a steroid-free approach to pediatric kidney transplant to a steroid-minimizing approach.
Both living- and deceased-donor kidney recipients are invited to join this study.
The control group gets a combination of anti-rejection medicines that are currently the standard of care at Seattle Children’s. The patient is given five doses of daclizumab, an interleukin-2 receptor blocker. One dose is given before transplantation and four doses are given after, at two-week intervals.
The maintenance anti-rejection medications will be tacrolimus, mycophenolate mofetil and prednisone.
In the study group, patients will get a double dose of daclizumab, followed by eight doses after transplant at two-week intervals. The maintenance medications will be tacrolimus and mycophenolate mofetil but not prednisone.
Along with other pediatric kidney programs across the country, we are investigating a new questionnaire for transplant patients.
We will determine whether the questionnaire is a useful tool to assess quality of life after transplant so that we can learn more about how best to serve our patients.
Seattle Children’s studies
We are conducting three of our own kidney transplant studies, including:
- A study to determine how soon after transplant children may develop viral infections, such as cytomegalovirus (CMV) or Epstein-Barr virus (EBV). The study’s goal is to prevent or treat the new viruses before they affect a patient’s health.
- A bone study to check bone metabolism after transplant
- A study that examines the effects of extended nutrition education after transplant
Intravenous Immunoglobulin (IVIG) for Highly Sensitized Patients
Patients with high levels of “anti-donor” antibodies often have very high rejection rates after transplant. This is especially true in kidney transplant.
Rejection risks are very high for a patient whose immune system has been exposed to “non-self” human leukocyte antigens (HLA). Exposure to HLAs may occur in a number of ways, including prior organ transplant or blood transfusions.
Seattle Children’s is now using intravenous immunoglobulin (IVIG) to increase a highly sensitized patient’s chance of successful transplant. IVIG is a new immune-modulating therapy that can reduce high antibody levels and improve transplant rates. IVIG helps by modifying the immune system rather than suppressing it.
IVIG is given while a highly sensitized patient waits for transplant, with the goal of decreasing their overall level of sensitization and thus increasing the possibility that a donor kidney would be acceptable to their immune system.
In a recent Cedars-Sinai Medical Center study, successful transplant rates for patients given IVIG were more than double that for a placebo group. For patients who had had a previous transplant, the IVIG group’s successful transplant rate was triple that of patients on placebo.