NCT01531257 Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
| NCT ID | NCT01531257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Acute Rejection (AR) of Transplanted Kidney |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2010-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2010-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic Allograft Nephropathy (CAN)/Interstitial fibrosis and Tubular Atrophy (IFTA) is responsible for most kidney transplant failures. CAN/IFTA on a 3 month kidney biopsy strongly predicts graft survival long term. CAN/IFTA remains a vexing problem for clinicians because current monitoring tools, namely the serum creatinine concentration, are not sensitive to early changes in glomerular filtration rate (GFR) or to histologic damage. Despite advances in prevention of acute rejection (AR), it is still a significant and potentially devastating complication of solid organ transplantation. One strategy to reduce the risk of rejection is to perform kidney biopsies to detect subclinical acute rejection (SCAR) and treat to prevent progression to rejection. There is evidence that treating SCAR can prevent further immune mediated injury to the kidney, a precursor to CAN/IFTA. Kidney biopsies provide better information but are limited due to safety concerns, patient preference and cost issues. Better, early and less invasive markers of CAN/IFTA will allow early intervention as well as improved graft and better patient outcomes. This study seeks to validate specific proteogenomic biomarker panels for AR and CAN/IFTA in a prospective blood, urine and kidney tissue monitoring study of kidney transplant recipients who will be scheduled for standard of care biopsies.
Eligibility 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
Contact & Investigator
Martha Castellini, BA
✉ martha.castellini@northwestern.eduSook H Park, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT01531257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Rejection (AR) of Transplanted Kidney. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01531257 currently recruiting?
Yes, NCT01531257 is actively recruiting participants. Contact the research team at martha.castellini@northwestern.edu for enrollment information.
Where is the NCT01531257 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT01531257 clinical trial?
NCT01531257 is sponsored by Northwestern University. The principal investigator is Sook H Park, MD at Northwestern University. The trial plans to enroll 1,000 participants.
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