Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
26 de febrero de 2015 actualizado por: Fresenius Medical Care Deutschland GmbH
Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.
Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.
In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.
The study is designed in three periods:
- Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
- Efficacy & Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
- Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
140
Fase
- Fase 3
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.
Ubicaciones de estudio
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Hannover, Alemania, 30659
- KfH-Nierenzentrum am Krankenhaus Oststadt
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Heidelberg, Alemania
- University Hospital of Heidelberg
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Köln, Alemania, 51109
- KfH-Nierenzentrum
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Offenburg, Alemania
- Nephrology center Offenburg
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Passau, Alemania, 94032
- KfH-Nierenzentrum
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Stuttgart, Alemania
- PHV - Nephrologisches Zentrum Stuttgart
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Trier, Alemania, 54292
- KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
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Copenhagen, Dinamarca
- Rigshospitalet
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Besançon, Francia, 25000
- CHU Saint-Jacques
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Caen, Francia, 14033
- CHRU
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Chambery, Francia
- Hospital of Chambéry
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Colmar, Francia
- CH Colmar
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Irigny, Francia
- Calydial Dialysis Center
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Paris, Francia
- Bichat-Claude Bernard Hospital
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Reims, Francia, 51726
- ARPDD
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Strasbourg, Francia
- CHRU de Strasbourg
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Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Reino Unido, BS10 5NB
- Southmead Hospital
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London, Reino Unido, E1 1BB
- The Royal London Hospital
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Shrewsbury, Reino Unido, SY3 8XQ
- Royal Shrewsbury Hospital
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Stoke on Trent, Reino Unido, ST47LN
- University of North Staffordshire - Renal Medicine - Royal Infirmary
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Wolverhampton, Reino Unido, WV10 0QP
- Wolverhampton New Cross Hospital
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Borås, Suecia
- Södra Älvborgsläns Hospital
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Göteborg, Suecia
- University Hospital of Sahlgrenska
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Lund, Suecia
- University Hospital of Lund
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Malmö, Suecia
- University Hospital of Malmö
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Skövde, Suecia
- Skarborgs Hospital
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Stockholm, Suecia, 14186
- Karolinska University Hospital
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Trollhättan, Suecia
- Norra Älvsborgs Hospital
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Chronic renal failure
- Stable patients on PD treatment
- Treatment at the study site for at least three months
- Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
- Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
- Patients aged 18 years or more
- Written consent to participate in the study (informed consent)
- Able to use a three-compartment bag
- Life expectancy and expected technical survival ≥ 9 months
Exclusion Criteria:
- Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
- Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
- Natremia < 130 mmol/l, after two consecutive measurements
- Chronic arrhythmia
- Pregnancy or lactation
- Participation in other studies during the study period which may affect the outcome of the present study
- Peritonitis within one month prior to the study start
- Exit site and /or tunnel infection
- Patients unable to tolerate 2 L bag exchanges
- Patients on non-compatible PD system
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: PDsol 12
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
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Treatment with one bag per day during 6 months
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Comparador activo: Gambrosol trio 40
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
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Treatment with one bag per day during 6 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline.
Periodo de tiempo: At the beginning and after 8 weeks of treatment
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At the beginning and after 8 weeks of treatment
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Measurement of Residual Renal Function
Periodo de tiempo: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Follow-up of frequency of hyponatremia, of AE and SAE
Periodo de tiempo: During whole period of the study
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During whole period of the study
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Assessment of changes in sodium removal
Periodo de tiempo: At the beginning and at two months of treatment
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At the beginning and at two months of treatment
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Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
Periodo de tiempo: At the beginning, at two and at six months of treatment
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At the beginning, at two and at six months of treatment
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Measurement of 24hours peritoneal clearance
Periodo de tiempo: At the beginning and at 2 months of treatment
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At the beginning and at 2 months of treatment
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Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
Periodo de tiempo: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Office systolic and diastolic blood pressure measurement during follow up period
Periodo de tiempo: End of treatment, follow-up period
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End of treatment, follow-up period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Simon Davies, Prof, University Hospital of North Staffordshire, Stoke-on-Trent, UK
- Silla de estudio: Bengt Rippe, Prof, Lund University
- Silla de estudio: Börje Haraldsson, Prof, Sahlgrenska University Hospital, Göteborg, Sweden
- Silla de estudio: François Vrtovsnik, Prof, Bichat -Claude Bernard Hospital, Paris, France
- Silla de estudio: Vedat Schwenger, Dr, Universitätsklinik University Hospital, Heidelberg, Germany
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 2008
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
18 de noviembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
19 de noviembre de 2008
Publicado por primera vez (Estimar)
20 de noviembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
26 de febrero de 2015
Última verificación
1 de septiembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1449 (Otro identificador: CSL Behring)
- EudraCT 2007-005365-35
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. .