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NCT04601155 · ClinicalTrials.gov registry record
Transition of Renal Patients Using AlloSure Into Community Kidney Care
A clinical trial of Kidney Transplant Rejection, sponsored by CareDx.
- Completed
- Registry status
- 248
- Enrollment target
- 18
- Study locations
NCT04601155: Completed study of Kidney Transplant Rejection, sponsored by CareDx.
NCT04601155 is a study of Kidney Transplant Rejection that has completed, run by CareDx. The registered enrollment target is 248 participants, below the 774-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (68% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04601155, a study of Kidney Transplant Rejection, has completed, sponsored by CareDx.
- COMPLETED
- Registry status
- 248 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
Time to allograft loss, defined as composite of: return to dialysis, re-transplant, death due to allograft failure, and death with functioning allograft.
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 |
What the finished NCT04601155 record still lists
NCT04601155 is an observational study that tracks outcomes without assigning an intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 774-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (68% lower).
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.
NCT04601155 lists 18 locations in 11 states (California, New York, Virginia).
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.
What interventions are being tested in trial NCT04601155?
The interventions under investigation include: AlloSure (DEVICE).
Who is sponsoring clinical trial NCT04601155?
This trial is sponsored by CareDx, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT04601155's enrollment target sits among peer trials
248 4th of 8 higher than 5 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
-
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
ACTIVE NOT RECRUITING
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The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
ACTIVE NOT RECRUITING
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Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
ACTIVE NOT RECRUITING
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