Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT) (IMPAKT)
17 de julio de 2026 actualizado por: Natera, Inc.
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
750
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Natera, Inc.
- Número de teléfono: 650-273-4468
- Correo electrónico: impakt@natera.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Brazo de control
|
|
|
Comparador activo: Test 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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.
Periodo de tiempo: From enrollment to 24 months post-transplant
|
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.
Periodo de tiempo: 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.
|
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.
Periodo de tiempo: 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.
|
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.
Periodo de tiempo: From enrollment to 24 months post-transplant
|
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.
Periodo de tiempo: 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.
|
From enrollment to 24 months post-transplant
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de julio de 2031
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 25-098-OH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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