Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNatera, Inc.
About this trial
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
Eligibility criteria
Qualifiers
Subjects received a kidney transplant in the prior 3 months.
Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment.
Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy.
18 years of age or older at time of signing informed consent.
Disqualifiers
Concurrent multiple solid organ or tissue transplants.
History of a previous organ transplant (aside from present kidney transplant), or cellular transplant.
DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity.
Any prior dd-cfDNA results ≥1.0% or ≥78cp/mL after 28 days post-transplant.
Trial design
Treatments tested in this trial
- Prospera Immunosuppression Optimization
Treatment groups
750 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov