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NCT03859388 · ClinicalTrials.gov registry record
Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
A clinical trial of Kidney Transplant Rejection and Rejection Chronic Renal, sponsored by Cedars-Sinai Medical Center.
- Active
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT03859388 is a study of Kidney Transplant Rejection and Rejection Chronic Renal that is active but no longer recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 10 participants, below the 804-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03859388, a study of Kidney Transplant Rejection and Rejection Chronic Renal, is active but no longer recruiting, sponsored by Cedars-Sinai Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Our group recently reported that tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, may be effective when administered monthly to patients with chronic antibody-mediated rejection (ABMR). The current paradigm to assess response to therapy involves serial monitoring for donor-specific antibodies, measurement of kidney function with creatinine, and periodic kidney transplant biopsies to survey for histologic findings indicative of ongoing ABMR. A new non-invasive blood test, donor-derived cell-free DNA (Allosure) has recently reported to have a high degree of discrimination for rejection and may be used to assess the likelihood of rejection. It has not been tested to see if it can be used to assess treatment response for rejection. This study will assess longitudinal changes in donor-derived cell-free DNA measurements in response to monthly therapy with tocilizumab for chronic ABMR and correlate these measurements to histologic changes on a follow-up kidney transplant biopsy.
Conditions Studied
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2025-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03859388
The ClinicalTrials.gov registry entry for NCT03859388 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 804-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (99% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT03859388 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03859388 about?
NCT03859388 is a clinical study titled "Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection". Our group recently reported that tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, may be effective when administered monthly to patients with chronic antibody-mediated rejection (ABMR). The current paradigm to assess response to therapy involves serial monitoring for donor-spe...
What is the current status of trial NCT03859388?
This trial is currently active not recruiting. The enrollment target is 10 participants. The study started on 2019-03-01. Estimated completion is 2025-12-31.
What conditions does trial NCT03859388 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection, Rejection Chronic Renal.
Who is sponsoring clinical trial NCT03859388?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03859388 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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