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

NCT07718633 | Not Yet Recruiting

• 1 other identifier: 25-098-OH
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Transplant; Immunosuppresion

Keywords

Kidney Transplant; Immunosuppression

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  From enrollment to 24 months post-transplant

• 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.

  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.

  From enrollment to 24 months post-transplant

Study Arms (2)

Control Arm

NO INTERVENTION

Test Arm

ACTIVE COMPARATOR

Diagnostic Test: Prospera Immunosuppression Optimization

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.

Test Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older at time of signing informed consent.
• Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject.
• Subjects are at the site standard-of-care MPA dosage

You may not qualify if:

• 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.
• ABO Incompatible donor.
• A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer).
• Pregnancy.
• Received any induction therapy other than IL2 receptor antagonist or thymoglobulin.
• Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone.
• Currently undergoing regular dialysis.
• Considered high-risk at the time of enrollment, as per the treating physician.
• Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.

Sponsors & Collaborators

• Natera, Inc.: lead

Central Study Contacts

Natera, Inc.

CONTACT

650-273-4468; impakt@natera.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-07