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Estudio abierto de dos brazos para evaluar la seguridad y el tiempo hasta CRBSI en sujetos desde el nacimiento hasta <18 años

22 de septiembre de 2026 actualizado por: CorMedix Therapeutics

Un estudio de etiqueta abierta, de dos brazos (DefenCath® frente al estándar de atención institucional) para evaluar la seguridad y el tiempo hasta las infecciones del torrente sanguíneo relacionadas con el catéter (CRBSI) en sujetos desde el nacimiento hasta los menores de 18 años con insuficiencia renal que reciben hemodiálisis mediante un catéter venoso central

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

36

Fase

  • Fase 4

Acceso ampliado

Ya no está disponible fuera del ensayo clínico. Ver registro de acceso ampliado.

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

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Reclutamiento
        • Children's of Alabama/University of Alabama
        • Contacto:
          • Sahar Fathallah-Shaykh, MD
          • Número de teléfono: 205-638-9781
          • Correo electrónico: sfshaykh@uabmc.edu
        • Contacto:
          • Susan Keeling
          • Número de teléfono: 205-638-2792
          • Correo electrónico: skeeling@uabmc.edu
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85016
        • Reclutamiento
        • Phoenix Children's Hospital
        • Contacto:
        • Contacto:
    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Reclutamiento
        • Stanford
        • Contacto:
        • Contacto:
    • Delaware
      • Wilmington, Delaware, Estados Unidos, 19803
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Reclutamiento
        • Hackensack University Medical Center
        • Contacto:
        • Contacto:
    • Texas
      • Fort Worth, Texas, Estados Unidos, 76104

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

No mayor que 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • All participants must be < 18 years of age and must meet the following inclusion criteria:
  • The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
  • A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.
  • The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.
  • The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.
  • The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.
  • The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.
  • The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.
  • The participant is not expected to expire within 180 days, based on clinical assessment.
  • Female participants of childbearing potential:
  • Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.
  • Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:
  • True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable).

Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.

  • Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
  • Bilateral tubal occlusion/ligation.
  • Intrauterine device.
  • Intrauterine hormone releasing system.
  • Vasectomized partner.
  • NOTE: If the childbearing potential changes after start of the study (e.g., a premenarchal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception, or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.
  • Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last administration of study treatment.

Exclusion Criteria:

  • Any participant who is currently receiving systemic antibiotics. Topical antibiotic use is permitted.
  • Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.
  • The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator [tPA] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.
  • The fill volume of catheter lumen(s) is unknown or cannot be determined.
  • The participant uses any type of antimicrobial-coated or heparin-coated catheter.
  • Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.
  • Documented history of an atrial thrombus or known hypercoagulable state.
  • The participant has open, non-healing skin ulcers.
  • Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  • The participant has current requirement for systemic chemotherapy and/or immunosuppression and absolute neutrophil count <500 cells/µL that occurred in the past 4 weeks.
  • An active malignancy that either in and of itself or by virtue of its treatment with chemotherapy or biologic therapy results in neutropenia, leukopenia and/or immunosuppression.
  • Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).
  • Unstable malignancy.
  • Cirrhosis with encephalopathy.
  • The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.
  • The participant is anticipated to receive a renal transplant within 90 days (participants can be on the transplant list, but a participant with a known or anticipated transplant date within the next 90 days should be excluded).
  • The participant has a clinically significant cardiac rhythm or functional disorder.
  • The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.
  • Any other medical condition which renders the participant unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the participant.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
Droga: Standard of Care

Site specific standard of care
Experimental: DefenCath®
Droga: (taurolidine and heparin) catheter lock solution

for central venous catheter instillation use

Otros nombres:
  • DefenCath®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)
Periodo de tiempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)
Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs
Periodo de tiempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to catheter removal due to CRBSI
Periodo de tiempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To evaluate the catheter removal due to CRBSI in pediatric participants who are receiving chronic HD through a CVC for kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CorMedix Therapeutics

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 (Actual)

8 de julio de 2025

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

2 de diciembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

2 de diciembre de 2024

Publicado por primera vez (Actual)

4 de diciembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PEDI-LOCK

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.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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