Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)

Sponsor
Natera, Inc.
Study ID
NCT07718633
Status
Not Yet Recruiting

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Conditions

  • Immunosuppresion
  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prospera Immunosuppression Optimization — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2031

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Arm
  • Active Comparator: Test Arm

Primary Outcome Measure

Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint [ Time Frame: From enrollment to 24 months post-transplant ]

Central Contacts

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