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Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

26 de marzo de 2012 actualizado por: Abbott

A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

  • 40% reduction in the base iPTH level is achieved, and/or;
  • serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Tipo de estudio

De observación

Inscripción (Actual)

237

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

  • Grecia
      • Athens, Grecia, 11526
        • Site Reference ID/Investigator# 32055
      • Athens, Grecia, 11528
        • Site Reference ID/Investigator# 32050
      • Athens, Grecia, 11528
        • Site Reference ID/Investigator# 32051
      • Athens, Grecia, 17237
        • Site Reference ID/Investigator# 32049
      • Athens, Grecia
        • Site Reference ID/Investigator# 5283
      • Chalkida, Grecia, 34100
        • Site Reference ID/Investigator# 32056
      • Chania, Grecia, 73100
        • Site Reference ID/Investigator# 32057
      • Drama, Grecia, 66100
        • Site Reference ID/Investigator# 32058
      • Holargos, Grecia, 15562
        • Site Reference ID/Investigator# 32077
      • Katerini, Grecia, 60100
        • Site Reference ID/Investigator# 32076
      • Kavala, Grecia, 65201
        • Site Reference ID/Investigator# 32059
      • Komotini, Grecia, 69100
        • Site Reference ID/Investigator# 32053
      • Lamia, Grecia, 35100
        • Site Reference ID/Investigator# 32060
      • Lefkada, Grecia, 31100
        • Site Reference ID/Investigator# 32061
      • Livadia, Grecia, 32100
        • Site Reference ID/Investigator# 32062
      • Pireus, Grecia
        • Site Reference ID/Investigator# 32048
      • Preveza, Grecia, 48100
        • Site Reference ID/Investigator# 32054
      • Ptolemaida, Grecia, 50200
        • Site Reference ID/Investigator# 32063
      • Volos, Grecia, 38222
        • Site Reference ID/Investigator# 32075

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

Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

Descripción

Inclusion Criteria:

  • Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
  • Subject is receiving chronic hemodialysis.
  • Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
  • Subject has provided their informed consent to participate.

Exclusion Criteria:

  • Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
  • Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
  • Subject has participated in clinical study within the last month.
  • Zemplar is contraindicated according to the Summary of Product Characteristics.

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
Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Periodo de tiempo: Baseline to Month 24 Visit
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
Baseline to Month 24 Visit
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Periodo de tiempo: Baseline to Month 24 Visit
The mean (average) number of days hospitalized per participant for those hospitalized during the study.
Baseline to Month 24 Visit

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
Periodo de tiempo: Baseline to Month 24 Visit
Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.
Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia
Periodo de tiempo: Baseline to Month 24 Visit
The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia
Periodo de tiempo: Baseline to Month 24 Visit
The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
Periodo de tiempo: Baseline to Month 24 Visit
The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.
Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs
Periodo de tiempo: Baseline to Month 24 Visit
The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.
Baseline to Month 24 Visit

Colaboradores e Investigadores

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

Patrocinador

Abbott

Investigadores

  • Silla de estudio: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.

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 diciembre de 2006

Finalización primaria (Actual)

1 de febrero de 2011

Finalización del estudio (Actual)

1 de febrero de 2011

Fechas de registro del estudio

Enviado por primera vez

27 de febrero de 2010

Primero enviado que cumplió con los criterios de control de calidad

4 de marzo de 2010

Publicado por primera vez (Estimar)

5 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de marzo de 2012

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

26 de marzo de 2012

Última verificación

1 de marzo de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • P06-120

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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