ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTransplant Genomics, Inc.
About this trial
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent and HIPAA authorization obtained prior to any study-related data collection.
Age ≥18 years at the time of enrollment.
Primary or repeat kidney transplantation
Living-donor or deceased-donor transplantation
Disqualifiers
Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
History of prior non-renal solid organ transplantation or islet cell transplantation.
Known pregnancy at the time of enrollment.
Hepatitis B surface antigen (HBsAg)-positive
Trial population
All subjects who meet eligibility criteria will be enrolled. As this is a non-interventional study, the protocol does not mandate any specific diagnostic, therapeutic, or management interventions. Clinical management decisions, including adjustments to immunosuppression, antiviral therapy, diagnostic testing, and biopsy decisions, remain entirely at the discretion of the treating clinicians.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood tests, TRAC( cell free DNA) and T-ID
Diagnostic testBlood collection
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The primary endpoint of the study is the time to first occurrence of either cytomegalovirus (CMV) disease or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months post-kidney transplantation.
* CMV disease will be defined according to standard clinical criteria, including CMV syndrome and/or tissue-invasive CMV disease, as determined by the treating clinician and documented in the medical record. * BK virus-associated nephropathy (BKVAN) will be defined as biopsy-proven BK virus nephropathy, characterized by histopathologic features consistent with BKVAN (including intranuclear viral inclusions and/or positive SV40 large T-antigen staining), in the setting of documented BK viral replication by standard-of-care testing (e.g., plasma or urine PCR).
Time frame
12 MonthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: