Monitoring kidney transplant recipients for rejection and damage
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
This study is trying to find better ways to monitor kidney transplant patients for signs of rejection and damage by collecting blood, urine, and biopsy samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT01531257 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on kidney transplant recipients to monitor and assess conditions like acute rejection and chronic allograft nephropathy. A total of 1000 subjects will be enrolled at Northwestern University, where they will undergo kidney biopsies at specified intervals or as needed. Blood, urine, and biopsy samples will be collected for proteomic analysis and gene expression profiling to better understand the early signs of kidney damage and rejection. The goal is to improve monitoring techniques beyond traditional methods, which may not detect early changes effectively.
Who should consider this trial
Good fit: Ideal candidates include adult kidney transplant recipients who are undergoing routine biopsies for monitoring purposes.
Not a fit: Patients requiring combined organ transplants or those with previous non-renal solid organ transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for kidney transplant recipients, potentially enhancing graft survival.
How similar studies have performed: Other studies have shown promise in using proteomic and genomic approaches for monitoring transplant rejection, indicating potential success for this methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female recipients of all races, ≥18 years of age. 2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation. 3. Subject and/or guardian must be able to provide informed consent. 4. Subject and/or guardian must be able to comply with the study protocol. Exclusion Criteria: 1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. 2. Recipients of previous non-renal solid organ and/or islet cell transplantation. 3. Infection with HIV. 4. Inability or unwillingness of a participant and/or guardian to provide informed consent
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Sook H Park, MD — Northwestern University
- Study coordinator: Martha Castellini, BA
- Email: martha.castellini@northwestern.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.