Kidney Transplant Recipients
Conditions
Keywords
kidney transplant, gene expression markers, renal allograft function
Brief summary
The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.
Detailed description
Gene expression profiling is used to study the activity of genes. Each gene has an on/off switch that controls how they are expressed in a cell, as well as a volume control that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.
Interventions
None listed
Sponsors
Genomics of Transplantation Cooperative Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years) conventional renal transplant recipient. * Patients who have given informed consent and are willing to comply with the protocol.
Exclusion criteria
* ABO incompatible kidney transplants. * Positive crossmatch kidney transplants (T cell crossmatch \>100, B flow cytometric crossmatch \>150). * Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study. * Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy. * An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 \[Days 301-420\] post-transplant).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function Decline | Baseline to 1 year | The primary endpoint for this study is defined as a progressive decline in renal function in participants with good function at 1 year. These Progressors are defined by all of the following criteria: 1. 1 year estimated GFR (eGFR) by MDRD equation of \>40 ml/min. 2. Decline in eGFR beyond 1 year during the time frame of this study (minimum 2.6 years after transplant and up to 5 years after transplant) with a slope of \<-6.1% (i.e. slope of decline of renal function is \>6.1%). 3. \>20% decline in eGFR from 1 year post-transplant to latest follow-up point. 4. At least one eGFR (MDRD) interval \< 60 ml/min. |
Countries
United States
Outcome results
None listed