Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients (PROGENI-KI)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Kidney Transplantation; Kidney Transplant

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01289717

DAIT CTOT-08

Details and patient eligibility

About

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

Full description

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers).

This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation
• Subject and/or parent guardian must be able to understand and provide informed consent
• Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry.

Exclusion criteria

• Need for combined organ transplantation with an extra-renal organ and/or islet
• Recipient of previous non-renal solid organ and/or islet cell transplantation
• Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.