Kidney TransplantIMPAKTNCT07718633
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
A study testing Prospera Immunosuppression Optimization in people with Kidney Transplant and Immunosuppresion, run by Natera, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Immunosuppresion
- What is being tested?
- Prospera Immunosuppression Optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Kidney Transplant, Immunosuppresion
- Being tested
- Prospera Immunosuppression Optimization
- Keywords
- Kidney Transplant, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospera Immunosuppression OptimizationDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Not described |
| Test Arm | Active comparator | Not described Receives: Diagnostic Test: Prospera Immunosuppression Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 24 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718633
- Sponsor's protocol ID
- 25-098-OH
- Acronym
- IMPAKT
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07718633
- Acronym / sponsor ID
- IMPAKT / 25-098-OH
- Conditions
- Kidney Transplant, Immunosuppresion
- Keywords
- Kidney Transplant, Immunosuppression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | – |
| Test Arm | Active comparator | Diagnostic Test: Prospera Immunosuppression Optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospera Immunosuppression OptimizationThe 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. | Diagnostic test | Test Arm |
Primary outcome
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
The rate of death, defined as related to the allograft, in the test and control arms will be calculated and compared.
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
Time frame: From enrollment to 24 months post-transplant
The rate of graft loss, defined as return to dialysis and/or retransplant, in the test and control arms will be calculated and compared.
Tier 3: Compare the number of randomized participants who experienced eGFR decline >30% between 6 and 24 months, using a win ratio hierarchical endpoint.
Time frame: From enrollment to 24 months post-transplant
The eGFR measurement will be calculated using the 2021 CKD-EPI formula without race.
Tier 4: Compare the number of randomized participants who experienced biopsy proven rejection requiring treatment with intravenous medications, using a win ratio hierarchical endpoint.
Time frame: From enrollment to 24 months post-transplant
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.
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.
Time frame: From enrollment to 24 months post-transplant
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.
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.
Time frame: From enrollment to 24 months post-transplant
The rate of de novo DSA, in the test and control arms will be calculated and compared.
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.
Time frame: From enrollment to 24 months post-transplant
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Prospera Immunosuppression Optimization in people with Kidney Transplant and Immunosuppresion, run by Natera, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natera, Inc. (650-273-4468, impakt@natera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.