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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: Active study of Kidney Transplant Rejection and Rejection Chronic Renal, sponsored by Cedars-Sinai Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in % donor-derived cell-free DNA/month
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 |
What the registry record for NCT03859388 still lists
NCT03859388 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 804-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT03859388 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Kidney Transplant Rejection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03859388's enrollment target sits among peer trials
10 9th of 8 the lowest of 8 other Kidney Transplant Rejection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant Rejection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Trifecta-Kidney cfDNA-MMDx Study
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Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
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Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
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Microbiome and Immunosuppression: The Mission Study
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The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
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Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
ACTIVE NOT RECRUITING
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