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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Prospera Immunosuppression Optimization
Diagnostic testThe test arm will include participants who are managed with routine clinical care, along with a standardized dd-cfDNA protocol, to guide optimization of immunosuppression dosages.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Test ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint
The rate of death, defined as related to the allograft, in the test and control arms will be calculated and compared.
Time frame
From enrollment to 24 months post-transplant2
Tier 2: Compare the number of randomized participants who experienced death censored graft loss (retransplant or return to dialysis), using a win ratio hierarchical endpoint
The rate of graft loss, defined as return to dialysis and/or retransplant, in the test and control arms will be calculated and compared.
Time frame
From enrollment to 24 months post-transplant3
Tier 3: Compare the number of randomized participants who experienced eGFR decline >30% between 6 and 24 months, using a win ratio hierarchical endpoint.
The eGFR measurement will be calculated using the 2021 CKD-EPI formula without race.
Time frame
From enrollment to 24 months post-transplant4
Tier 4: Compare the number of randomized participants who experienced biopsy proven rejection requiring treatment with intravenous medications, using a win ratio hierarchical endpoint.
The rate of biopsy proven rejection by histology and the rate of treated rejection in the two arms between months 6 and 24 will be measured and compared.
Time frame
From enrollment to 24 months post-transplantLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: