- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00649298
A Clinical Trial of IntensiVE Dialysis (ACTIVE)
ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.
In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.
The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Australian Capital Territory
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Canberra, Australian Capital Territory, Australia
- The Canberra Hospital
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New South Wales
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Sydney, New South Wales, Australia, 2076
- Sydney Adventist Hospital
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Sydney, New South Wales, Australia
- Liverpool Hospital
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Sydney, New South Wales, Australia, 2050
- RPAH/Concord
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Sydney, New South Wales, Australia
- Sydney Dialysis Centre
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Queensland
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Brisbane, Queensland, Australia
- Princess Alexandra Hospital
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Brisbane, Queensland, Australia
- Royal Brisbane Hospital
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Gold Coast, Queensland, Australia
- Gold Coast Hospital
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Nambour, Queensland, Australia
- Nambour General Hospital
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Tasmania
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Hobart, Tasmania, Australia
- Royal Hobart Hospital
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Victoria
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Melbourne, Victoria, Australia
- Royal Melbourne Hospital
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Melbourne, Victoria, Australia
- Austin Hospital
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Melbourne, Victoria, Australia
- Monash Medical Centre
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Western Australia
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Perth, Western Australia, Australia
- Sir Charles Gairdner Hospital
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British Columbia
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Vancouver, British Columbia, Canadá
- UBC
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Ontario
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Toronto, Ontario, Canadá
- University Health Network
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Toronto, Ontario, Canadá, M5B 1W8
- St Michael's Hospital
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Auckland, Nueva Zelanda
- Auckland City Hospital
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Auckland, Nueva Zelanda
- North Shore Hospital
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Beijing
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Beijing, Beijing, Porcelana
- Beijing Tongren Hospital
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Beijing, Beijing, Porcelana
- Beijing Hospital of Traditional Chinese Medicine
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Chaoyang District, Beijing, Porcelana
- China-Japan Friendship Hospital
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Chaoyang District,, Beijing, Porcelana
- Civil Aviation General Hospital
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Haidian District, Beijing, Porcelana
- First Affiliated Hospital of Chinese PLA General Hospital
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Xicheng District, Beijing, Porcelana
- Beijing Hospital
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Xicheng District, Beijing, Porcelana
- Peking University First Hospital
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Xicheng District, Beijing, Porcelana
- Peking University People's Hospital
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Guangdong
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Shenzhen, Guangdong, Porcelana
- Shenzhen Hospital of Peking University
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Hebei
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Shijiazhuang, Hebei, Porcelana
- Fourth Hospital Affiliated to Hebei Medical University
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Shijiazhuang, Hebei, Porcelana
- Shijiazhuang First People's Hospital
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Shijiazhuang, Hebei, Porcelana
- Third Hospital Affiliated to Hebei Medical University
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Henan
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Zhengzhou, Henan, Porcelana
- Zhengzhou University affiliated first hospital
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Inner Mongolia
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Baotou, Inner Mongolia, Porcelana
- First Affiliated Hospital of Inner Mongolia, Baotou Medical College
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Zhongda Hospital, Southeast University
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Jilin
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Changchun, Jilin, Porcelana
- Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
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Liaoning
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Dalian, Liaoning, Porcelana
- Dalian Medical affiliated first hospital
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Shanghai
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Shanghai, Shanghai, Porcelana
- Shanghai Ruijin Hospital
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Shanghai, Shanghai, Porcelana
- The Chinese PLA Shanghai 85th Hospital
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Shanxi
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Taiyuan City, Shanxi, Porcelana
- The Second Affiliated Hospital of Shanxi Medical University
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Sichuan
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Chengdu, Sichuan, Porcelana
- Huaxi Hospital of Sichuan University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
Exclusion Criteria:
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: extended hours
24 or more hours per week of hemodialysis
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Comparison of different weekly duration of haemodialysis treatment
Otros nombres:
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Comparador activo: standard hours
18 or less hours per week of hemodialysis
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Comparison of different weekly duration of haemodialysis treatment
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument.
Periodo de tiempo: 12 months from randomisation
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12 months from randomisation
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Survival and cardiovascular analyses
Periodo de tiempo: 12 months
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12 months
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Quality of life and patient acceptability
Periodo de tiempo: 12 months
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12 months
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Safety outcomes
Periodo de tiempo: 12 months
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12 months
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Costs associated with each intervention
Periodo de tiempo: 12 months
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12 months
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Changes in biochemical and haematological parameters
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vlado Perkovic, MBBS PhD, The George Institute
Publicaciones y enlaces útiles
Publicaciones Generales
- Jardine MJ, Zuo LI, Gray NA, de Zoysa J, Chan CT, Gallagher MP, Howard K, Hertier S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee. Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': the ACTIVE Dialysis Study. Nephrology (Carlton). 2015 Apr;20(4):257-65. doi: 10.1111/nep.12385.
- Smyth B, van den Broek-Best O, Hong D, Howard K, Rogers K, Zuo L, Gray NA, de Zoysa JR, Chan CT, Lin H, Zhang L, Xu J, Cass A, Gallagher M, Perkovic V, Jardine M. Varying Association of Extended Hours Dialysis with Quality of Life. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1751-1762. doi: 10.2215/CJN.06800619. Epub 2019 Oct 31.
- Jardine MJ, Zuo L, Gray NA, de Zoysa JR, Chan CT, Gallagher MP, Monaghan H, Grieve SM, Puranik R, Lin H, Eris JM, Zhang L, Xu J, Howard K, Lo S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee; Paul. A Trial of Extending Hemodialysis Hours and Quality of Life. J Am Soc Nephrol. 2017 Jun;28(6):1898-1911. doi: 10.1681/ASN.2015111225. Epub 2017 Feb 1.
- Zhan Z, Smyth B, Toussaint ND, Gray NA, Zuo L, de Zoysa JR, Chan CT, Jin C, Scaria A, Hawley CM, Perkovic V, Jardine MJ, Zhang L. Effect of extended hours dialysis on markers of chronic kidney disease-mineral and bone disorder in the ACTIVE Dialysis study. BMC Nephrol. 2019 Jul 12;20(1):258. doi: 10.1186/s12882-019-1438-3.
- Liao JL, van den Broek-Best O, Smyth B, Hong D, Vo K, Zuo L, Gray NA, Chan CT, de Zoysa J, Perkovic V, Jiang L, Jardine M. Effect of extended hours dialysis on sleep quality in a randomized trial. Nephrology (Carlton). 2019 Apr;24(4):430-437. doi: 10.1111/nep.13236.
- Gray NA, Zuo L, Hong D, Smyth B, Jun M, De Zoysa J, Vo K, Howard K, Wang J, Lu C, Liu Z, Cass A, Perkovic V, Jardine M. Quality of life in caregivers compared with dialysis recipients: The Co-ACTIVE sub-study of the ACTIVE dialysis trial. Nephrology (Carlton). 2019 Oct;24(10):1056-1063. doi: 10.1111/nep.13530. Epub 2019 Apr 29.
- Badve SV, Hawley CM, Johnson DW. Frequent versus standard hemodialysis. N Engl J Med. 2011 Mar 10;364(10):975; author reply 976. doi: 10.1056/NEJMc1100105. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Infección
- Carrera
- Enfermedades cardiovasculares
- Calidad de vida
- Hipertensión
- Anemia
- Hematínicos
- Ensayo controlado aleatorizado
- Trombosis
- Mortalidad
- Ensayo clínico
- Presión arterial
- El síndrome coronario agudo
- Hemodiálisis
- Infarto de miocardio
- Diálisis extendida
- Terapia de reemplazo renal
- Diálisis renal
- Hospitalización
- Estudio multicéntrico
- Trastornos cerebrovasculares
- Hipertrofia Ventricular Izquierda
- Fístula arteriovenosa
- Ensayo Clínico Controlado
- Análisis de costos
- Enfermedad renal en etapa terminal
- Evaluación económica
- Costos de atención médica
- Agentes estimulantes de la eritropoyesis
- El gasto en salud
- Clinical Trial, Phase IV
- Nocturnal Dialysis
- Quality Adjusted Life Year
- Cost-utility Analysis
- Health Care Utilisation
- Arteriovenous Shunt, Surgical
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GI-R-A001- 09
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