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
Qualifiers
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 design
Treatments tested in this trial
- Blood tests, TRAC( cell free DNA) and T-ID
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov