Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Transition of Renal Patients Using AlloSure Into Community Kidney Care
NCT04601155 · View on ClinicalTrials.gov ↗
Study Summary
Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.
Conditions Studied
Interventions
- DEVICE AlloSure
Study Locations (18)
California
- Amicis Research Center — Fairfield
- The Medical Research Group - Fresno — Fresno
- Amicis Research Center — Granada Hills
- Amicis Research Center — Mission Hills
- California Institute of Renal Research (Balboa) — San Diego
New York
- PRINE Health — Manhasset
- Chinatown Kidney — New York
- Nephrology Associates PC, Queens — Queens
Virginia
- Lynchburg Nephrology Physicians, PLLC — Lynchburg
- Mendez Center for Clinical Research — Woodbridge
Connecticut
- Starling Physicians — Hartford
District of Columbia
- George Washington/Medical Faculty Associates Inc. — Washington D.C.
Georgia
- Physician Consultants of Georgia — Macon
Illinois
- NANI Research — Hinsdale
Indiana
- NANI Research — Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2023-10-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04601155
The ClinicalTrials.gov registry entry for NCT04601155 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CareDx, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 1 intervention — of which AlloSure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04601155 reports 18 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04601155 about?
NCT04601155 is a clinical study titled "Transition of Renal Patients Using AlloSure Into Community Kidney Care". Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA te...
What is the current status of trial NCT04601155?
This trial is currently completed. The enrollment target is 248 participants. The study started on 2020-11-19. Estimated completion is 2023-10-06.
What conditions does trial NCT04601155 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04601155?
The interventions under investigation include: AlloSure (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04601155?
This trial is sponsored by CareDx, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04601155 being conducted?
This trial has 18 study locations across California, Connecticut, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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