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Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

11 de enero de 2013 actualizado por: AbbVie (prior sponsor, Abbott)

Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary

This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.

Tipo de estudio

De observación

Inscripción (Actual)

60

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

  • Hungría
      • Budapest, Hungría, 1083
        • Site Reference ID/Investigator# 46593
      • Budapest, Hungría, 1115
        • Site Reference ID/Investigator# 46585
      • Debrecen, Hungría, 4012
        • Site Reference ID/Investigator# 46594
      • Gyor, Hungría, 9023
        • Site Reference ID/Investigator# 47722
      • Karcag, Hungría, 5301
        • Site Reference ID/Investigator# 46592
      • Karcag, Hungría, 5301
        • Site Reference ID/Investigator# 58644
      • Miskolc, Hungría, 3501
        • Site Reference ID/Investigator# 46595
      • Nyiregyhaza, Hungría, 4400
        • Site Reference ID/Investigator# 46588
      • Pecs, Hungría, 7624
        • Site Reference ID/Investigator# 46597
      • Szombathely, Hungría, 9700
        • Site Reference ID/Investigator# 46590
      • Veszprem, Hungría, 8200
        • Site Reference ID/Investigator# 46591

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

Método de muestreo

Muestra no probabilística

Población de estudio

Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary

Descripción

Inclusion Criteria:

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:

  1. ≥ 18 years of age,
  2. Willing to sign the patient information and informed consent form,

  3. Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:

    • between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
    • higher than 800 pg/mL and parathyroidectomy is contraindicated.
  4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Exclusion Criteria:

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:

  1. The patient is already treated with Zemplar (paricalcitol injection),
  2. Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
  3. Patients who decline to participate in the study or decline to sign the patient information/informed consent form.

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

Cohortes e Intervenciones

Grupo / Cohorte
End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Periodo de tiempo: 6 months
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Periodo de tiempo: 6 months
Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
6 months
Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
Periodo de tiempo: 6 months prior to start of study through 6 months of treatment
If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
Periodo de tiempo: 6 months prior to start of study through 6 months of treatment
If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
6 months prior to start of study through 6 months of treatment
Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
Periodo de tiempo: 6 months prior to start of study through 6 months of treatment
If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
6 months prior to start of study through 6 months of treatment
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Periodo de tiempo: 6 months prior to start of study through baseline
Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
6 months prior to start of study through baseline
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Periodo de tiempo: 6 months
Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
6 months
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Periodo de tiempo: 6 months prior to start of study through baseline
Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
6 months prior to start of study through baseline
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Periodo de tiempo: 6 months
Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
6 months

Colaboradores e Investigadores

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

Patrocinador

AbbVie (prior sponsor, Abbott)

Colaboradores

Planimeter Ltd

Investigadores

  • Director de estudio: Tamas Schnaider, AbbVie (prior sponsor, Abbott)

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.

Enlaces Útiles

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 enero de 2011

Finalización primaria (Actual)

1 de noviembre de 2011

Finalización del estudio (Actual)

1 de noviembre de 2011

Fechas de registro del estudio

Enviado por primera vez

22 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

7 de enero de 2011

Publicado por primera vez (Estimar)

10 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de enero de 2013

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

11 de enero de 2013

Última verificación

1 de enero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • P12-644

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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