Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.

This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.

Inclusion Criteria:

• Candidate for deceased donor or living donor kidney transplant
• Negative Crossmatch
• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Clinically significant liver disease
• Other illnesses that, in the opinion of the investigator, may interfere with the study
• Recipient of multiple organ transplants
• Inability or unwillingness to comply with the study protocol