- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00412139
Serum Uremic Toxins and Histological Findings of the Blood Vessels in Dialysis Patients
A Correlation Between Histological Findings of the Blood Vessels in Patients With Chronic Renal Failure and Serum Uremic Toxins and Its Diagnostic Performance in the Assessment of the Cardiovascular Morbidity and Mortality
Patients treated by chronic renal replacement therapy are exposed to cardiovascular problems and suffer from an accelerated and sever atherosclerosis. Classical risk factors for atherosclerosis and cardiovascular diseases (CVD) do not explain the full risk of CVD in the dialysis patients. Additional risk factors are therefore likely to exist. The uremic syndrome is attributed to the progressive retention of a large number of compounds, which under normal conditions are excreted by the healthy kidneys. Uremic toxins such are parathormone (PTH), vitamin D and phosphates, cause development of renal osteodystrophy (ROD), i.e. disordered calcium and phosphate metabolism. Both conditions of hyperparathyroid and adynamic bone disease (ABD) lead to an elevated calcium x phosphate product and increased vascular calcification, which might occur in intimal and medial layer of the vessel wall. It is important to consider these processes separately, as the vascular consequences (occlusion with atheromatosis and vascular stiffening through medial calcification) are different. Moreover, the difference between uremic and non-uremic intimal plaque is not the size but its composition, with markedly increased calcium content. Hence, these observations have an important socio-economic impact because of the increased cardiovascular morbidity and mortality.
The investigators hypothesized that uremic toxins in dialysis patients influence directly and/or indirectly the development of atherosclerosis, vascular calcifications and CVD.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Rationale: Patients treated by chronic renal replacement therapy are exposed to cardiovascular problems and suffer from an accelerated and sever atherosclerosis. Classical risk factors for atherosclerosis and cardiovascular diseases (CVD) do not explain the full risk of CVD in the dialysis patients. Additional risk factors are therefore likely to exist. The uremic syndrome is attributed to the progressive retention of a large number of compounds, which under normal conditions are excreted by the healthy kidneys. Uremic toxins such are parathormone (PTH), vitamin D and phosphates, cause development of renal osteodystrophy (ROD), i.e. disordered calcium and phosphate metabolism. Both conditions of hyperparathyroid and adynamic bone disease (ABD) lead to an elevated calcium x phosphate product and increased vascular calcification, which might occur in intimal and medial layer of the vessel wall. It is important to consider these processes separately, as the vascular consequences (occlusion with atheromatosis and vascular stiffening through medial calcification) are different. Moreover, the difference between uremic and non-uremic intimal plaque is not the size but its composition, with markedly increased calcium content. Hence, these observations have an important socio-economic impact because of the increased cardiovascular morbidity and mortality.
Hypothesis: We hypothesized that uremic toxins in dialysis patients influence directly and/or indirectly the development of atherosclerosis, vascular calcifications and CVD.
Objectives:
To asses the histology of arterial vessels in patients with end-stage renal failure and to evaluate its relationship with serum uremic toxins.
To determine the biochemical and clinical risk factors that might influence the development of vascular calcifications and their diagnostic performance in the assessment of CVD morbidity and mortality.
Methods: A cross-sectional study will be conducted at the Department of Nephrology Skopje. After the initial assessment patients will be followed for 2 years as the prospective part of the study.
Seventy-five to ninety patients will be included, during one-year period or until proposed number of patients is recruited. The study cohort will be divided to 3 subgroups: 1) patients at the initiation of dialysis therapy, 2) patients on regular dialysis treatment for a few years and 3) patients undergoing renal transplantation. During the follow-up period cardiovascular and cerebrovascular events and the moment of their occurrence will be recorded, as well as the peripheral vascular diseases. Moreover, clinical, laboratory data and arterial vessel samples for histology will be collected at the moment of inclusion.
Expected outcomes: We expect the determination of high correlation coefficient between histological parameters and various uremic toxins, which are responsible for development atherosclerosis and vascular calcifications, leading to an accelerated progression of CVD in dialysis patients. This determination could help to design new preventive therapeutic tools in these patients. The result of this work will impose a positive impact on quality of life and therapeutic costs related to atherosclerosis not only in the dialysis populations but also in the pre-dialysis chronic renal failure populations and kidney transplant recipients.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Skopje, Macedonia, la ex República Yugoslava de, 1000
- Department of Nephrology, University Clinical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Chronic renal failure patients with a need for creation of AV fistula
- Dialysis patients with a need of reanastomosing of the AV fistula (thrombosis or insufficient blood flow)
Exclusion Criteria:
- Diabetes
- Malignant disease
- Prior treatment with corticosteroids
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Caso cruzado
- Perspectivas temporales: Futuro
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Goce Spasovski, MD, PhD, Department of Nephrology, University Clinical Center, Vodnjanska 17, 1000 Skopje, R. Macedonia
- Silla de estudio: Momir Polenakovic, MD, PhD, Macedonian Academy of Science and Arts
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-1001/2-05
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .
Ensayos clínicos sobre Falla renal cronica
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and Kidney... y otros colaboradoresReclutamientoEnfermedades Renales Crónicas | Fallo renal agudo | Lesión renal aguda | Insuficiencia Renal Aguda | Insuficiencia renal cronica | Insuficiencia Renal, Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia Renal Aguda | Insuficiencia renal aguda | Insuficiencia Renal Crónica | Enfermedades... y otras condicionesEstados Unidos
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillTerminadoEnfermedades Renales Crónicas | Enfermedad Renal Crónica Etapa 5 | Enfermedad Renal Crónica etapa 4 | Enfermedad renal pediátrica | Enfermedad Renal Crónica etapa 3 | Enfermedad Renal Crónica Etapa V | Enfermedad renal crónica, estadio IV (grave) | Enfermedad Renal Crónica Etapa 2 | Enfermedad Renal...Estados Unidos
-
University Hospital, BordeauxMinistry of Health, FranceTerminadoTrasplante Renal | Enfermedad renal crónica en etapa terminal | Insuficiencia Renal Aguda SeveraFrancia
-
Wake Forest University Health SciencesStanford UniversityTerminadoTrasplante Renal | Rechazo Renal Agudo | Rechazo Renal Crónico | Rechazo de Trasplante Renal | Sistema Renina-AngiotensinaEstados Unidos
-
Outset MedicalTerminadoLesión renal aguda | Enfermedad renal en etapa terminal (ESRD) | Enfermedad renal en etapa terminal en diálisisEstados Unidos
-
Novartis PharmaceuticalsTerminadoHemodiálisis | Terapia de reemplazo renal | Enfermedad renal en etapa terminal (ESRD) | Trasplante Renal | Enfermedad renal crónica (ERC)Alemania, Estados Unidos, Bélgica, Italia, España, Croacia, Taiwán, Australia, Austria, Grecia, Corea, república de, Líbano, Chequia, Israel, Países Bajos, Eslovenia, Suiza, Tailandia, Noruega, Pavo, Suecia, Argentina, Brasil, Japón, Serbia, Federación Rusa y más
-
Faculdade de Ciências Médicas da Santa Casa de...TerminadoEnfermedad Renal Crónica | Diálisis renalBrasil
-
ArdelyxAstraZenecaTerminadoEnfermedad renal en etapa terminal | ESRD | Enfermedad Renal Crónica Etapa 5Estados Unidos
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)TerminadoFallo renal agudo | Insuficiencia renal cronicaAustria
-
Angiodynamics, Inc.TerminadoEnfermedad Renal Crónica | Lesión renal aguda | Fallo renal agudo | Insuficiencia renal crónica inducida por contrasteEstados Unidos