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.
The IMPAKT study is a multi-center randomized controlled trial (RCT) in which stable low-risk kidney transplant (Tx) recipients receiving maintenance immunosuppression with tacrolimus, MPA dosage with or without corticosteroids will be randomized to the Immunosuppression optimization (Test) arm or the Standard of Care (SoC) Immunosuppression (Control) arm. Participants will be enrolled at three months posttransplant and monitored with routine standard of care treatment and monthly Prospera blood draws from enrollment to 6 months posttransplant. All subjects will follow their center's SoC immunosuppressive therapy (IST) from enrollment to 6 months post-transplant. Subjects will be randomized at 6 months post-transplant to either the Test arm versus the Control arm. The 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. The control arm will include subjects who are managed with routine clinical care and receiving the standard of care (SoC) immunosuppression. This RCT will compare a hierarchical composite end point between the test and the control arm at 24 months post-transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
The 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.
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-transplant
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-transplant
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-transplant
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-transplant
Tier 5: Compare the number of randomized participants who experienced transplant-related hospitalization ≥2 nights not related to biopsy proven rejection, using a win ratio hierarchical endpoint.
The average number of nights spent at an inpatient facility for graft-related issues, but not including biopsy proven rejection, by subjects in the test and control arms will be measured and compared.
Time frame: From enrollment to 24 months post-transplant
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Tier 6: Compare the number of randomized participants who developed de novo DSA after 6 months, and by 24 months, using a win ratio hierarchical endpoint.
The rate of de novo DSA, in the test and control arms will be calculated and compared.
Time frame: From enrollment to 24 months post-transplant
Tier 7: Compare the number of randomized participants who experienced adverse outcome (AO), defined as GI Toxicity, Leukopenia, and/or Infection, using a win ratio hierarchical endpoint.
The Adverse Outcome (AO) rate at 24 months post-Tx will be compared between the test arm and the control arm, with the list of events qualifying as AO comprising: GI toxicity, leukopenia, and infection.
Time frame: From enrollment to 24 months post-transplant