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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 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.

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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.

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2010-04
Est. Completion 2026-12

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT01531257

The ClinicalTrials.gov registry entry for NCT01531257 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.