- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00396032
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters (TROPICS 3)
1 de mayo de 2010 actualizado por: Genentech, Inc.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters
This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States.
150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
150
Fase
- Fase 3
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
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Clinically stable, in the opinion of the investigator
- Use of a cuffed, tunneled HD catheter
- HD prescribed at a BFR of ≥300 mL/min
- Baseline BFR (at any time during the first 60 minutes of HD) of <300 mL/min at an associated pre-pump negative arterial pressure in the range between and including -240 mmHg and -280 mmHg
- Baseline BFR (at any time during the first 60 minutes of HD) at least 25 mL/min below the prescribed BFR
- Demonstrated BFR of ≥300 mL/min (using catheter lines in the customary direction) at an arterial pressure in the range of 0 to -280 mmHg in at least one HD session in the 14 days prior to Visit 1
- Anticipated use of the same catheter for at least four consecutive HD sessions, on the same type and model of HD apparatus
- Able to have fluids infused at the volume necessary to instill study drug into the HD catheter
Exclusion Criteria:
- HD catheter with sustainable BFR of ≥300 mL/min following subject repositioning
- HD catheter inserted <2 days prior to screening
- Evidence of a mechanical, non-thrombotic cause of HD catheter dysfunction (e.g., kink in the catheter or suture constricting the catheter) or dysfunction caused by known fibrin sheath
- Use of an implantable port
- HD catheter that is internally coated with any therapeutic agent (e.g., the Decathlon™ Gold catheter)
- Anticipated use of catheter for any other type of diagnostic or therapeutic procedure (i.e., other than HD) during study drug treatment
- Previously treated in this study or any tenecteplase catheter clearance trial
- Use of any investigational drug or therapy (defined as any drug or therapy that is not FDA approved) within 28 days prior to screening
- Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 7 days prior to Visit 1
- Known to be pregnant or breastfeeding at screening or at Visit 1
- Known bacteremia or known or suspected infection in the HD catheter
- Known history of any of the following: intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation
- Use of heparin (unfractionated or low molecular weight) or other anticoagulants (e.g., for the treatment of heparin-induced thrombocytopenia) within 24 hours prior to Visit 1, except for heparin used only during HD or for prophylaxis (e.g., heparin lock or deep vein thrombosis prophylaxis)
- Subjects treated with warfarin only: international normalized ratio (INR) >3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR >3.0 A laboratory test to confirm the INR must have been performed within 7 days prior to Visit 1.
- Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to Visit 1
- Hemoglobin ≥12.0 g/dL if on an erythropoiesis-stimulating agent (e.g., darbepoetin or erythropoietin) and the dose of the erythropoiesis-stimulating agent has not been held or reduced per institutional policy
- At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
- BFR of <300 mL/min because of symptomatic hypotension
- Uncontrolled hypertension in the opinion of the investigator
- Known hypersensitivity to tenecteplase or any component of the formulation
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
|
For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
|
Comparador de placebos: 2
|
For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1
Periodo de tiempo: Visit 1 of HD treatment
|
Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
|
Visit 1 of HD treatment
|
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2
Periodo de tiempo: Visits 1 and 2 of consecutive HD treatments
|
Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications
|
Visits 1 and 2 of consecutive HD treatments
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in BFR From Baseline to the End of HD at Visit 1
Periodo de tiempo: Visit 1 of HD treatment
|
BFR is measured in mL/minute.
|
Visit 1 of HD treatment
|
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)
Periodo de tiempo: Visit 2 of consecutive HD treatments
|
Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
|
Visit 2 of consecutive HD treatments
|
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)
Periodo de tiempo: Visit 2 of consecutive HD treatments
|
Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.
|
Visit 2 of consecutive HD treatments
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Barbara Gillespie, M.D., FASN
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de octubre de 2006
Finalización primaria (Actual)
1 de diciembre de 2008
Fechas de registro del estudio
Enviado por primera vez
2 de noviembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
2 de noviembre de 2006
Publicado por primera vez (Estimar)
6 de noviembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de junio de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2010
Última verificación
1 de mayo de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- N3700g
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. .