Post Marketing Observational Study on Paricalcitol IV Administered to Venezuelan Patients
7 de noviembre de 2014 actualizado por: AbbVie (prior sponsor, Abbott)
A Prospective, Multicenter, Six-Month Study on the Effectiveness, Safety and Impact on Health Related Quality of Life (HRQoL) and Depression Symptoms of Paricalcitol Administered to Venezuelan Patients With Chronic Kidney Disease (Stage V) Who Are on Hemodialysis
This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
105
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
-
-
-
Acarigua, Venezuela
- Site Reference ID/Investigator# 96757
-
Barquisimeto, Venezuela
- Site Reference ID/Investigator# 96766
-
Caracas, Venezuela
- Site Reference ID/Investigator# 96768
-
Maracaibo, Venezuela
- Site Reference ID/Investigator# 96760
-
Maracaibo, Venezuela
- Site Reference ID/Investigator# 96761
-
Miranda, Venezuela
- Site Reference ID/Investigator# 96770
-
Monagas, Venezuela
- Site Reference ID/Investigator# 96763
-
Naguanagua, Venezuela
- Site Reference ID/Investigator# 96765
-
-
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
This study was conducted in 8 hemodialysis units distributed in Venezuela.
Descripción
Inclusion Criteria:
- Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline
- Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol
- Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela
- Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study
- Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment
Exclusion Criteria:
- Subjects with severe hyperparathyroidism (parathyroid hormone [PTH] > 3000 pg/mL)
- Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70
- Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol)
- Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product
- Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum
- Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits
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 |
|---|
|
Paricalcitol IV
Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
Periodo de tiempo: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
|
Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
Periodo de tiempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL). |
Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
|
Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL
Periodo de tiempo: Baseline to Week 12, Week 12 to Week 24
|
Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).
|
Baseline to Week 12, Week 12 to Week 24
|
|
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks
Periodo de tiempo: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
|
Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).
|
Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
|
|
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24
Periodo de tiempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS).
For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.
|
Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
|
European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24
Periodo de tiempo: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS.
For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).
|
Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
|
|
Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
Periodo de tiempo: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)
|
BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression.
The range of scores is 0 to 63, with a higher value representing a worse outcome.
|
Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Jeanine Obage, MD, Abbott
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 2013
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
27 de diciembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
27 de diciembre de 2012
Publicado por primera vez (Estimar)
1 de enero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
7 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P13-785
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. .