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NCT01531257 · ClinicalTrials.gov registry record
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
A clinical trial of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN), sponsored by Northwestern University.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT01531257: Recruiting study of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN), sponsored by Northwestern University.
NCT01531257 is a study of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN) that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 1,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531257, a study of Acute Rejection (AR) of Transplanted Kidney and Chronic Allograft Nephropathy (CAN), is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Full blood tube set, urine sample for proteomics and flow cytometry of urinary sediment, and an extra core kidney biopsy tissue for gene expression profiling will be collected from subjects at the time of any biopsies obtained during the study course. Whole genome expression profiling will be done using Affymetrix GeneChips at The Scripps Research Institute.
Conditions Studied
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2010-04 |
| Est. Completion | 2026-12 |
What NCT01531257 shows while recruiting
NCT01531257 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 4 conditions, with Acute Rejection (AR) of Transplanted Kidney appearing as the primary indexed condition, and to 0 interventions.
NCT01531257 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01531257 about?
NCT01531257 is a clinical study titled "Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients". 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, ...
What is the current status of trial NCT01531257?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2010-04. Estimated completion is 2026-12.
What conditions does trial NCT01531257 study?
This clinical trial studies the following conditions: Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN), Interstitial Fibrosis (IF), Tubular Atrophy (TA).
Who is sponsoring clinical trial NCT01531257?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01531257 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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