- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00091975
Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
17 de enero de 2011 actualizado por: Abbott
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción
78
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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California
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San Diego, California, Estados Unidos, 92120
- California Institute of Renal Research
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 60057
- Georgetown University Medical Center
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Florida
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Fort Meyers, Florida, Estados Unidos, 33908
- Associates in Nephrology
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Hudson, Florida, Estados Unidos, 34667
- Outcomes Research International, Inc.
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Evanston Northwestern Healthcare
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112-2699
- Tulane University School of Medicine
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- St. Louis University
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St. Louis, Missouri, Estados Unidos, 63108
- Washington University Medical Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- Nea Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267-0585
- University of Cincinnati College of Medicine
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Northwestern Renal Clinic, INC.
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- Nephrology Associates, P.C.
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Texas
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Houston, Texas, Estados Unidos, 77030
- Kidney Associates, PLLC
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Center at San Antonio
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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
- Subject was at least 18 years of age, diagnosed with CKD Stage 5 and undergoing HD or PD.
- If female, subject was either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or was of childbearing potential and practicing 1 of the protocol specified methods of birth control, was not breastfeeding and had a negative serum pregnancy test prior to the Treatment Phase.
- For those subjects taking phosphate binders prior to the study, the subject had to have been on a stable (type and dose) phosphate binder at least 4 weeks prior to the Pretreatment Phase.
- For entry into the Pretreatment Phase, the subject must have had a calcium level <= 10.5 mg/dL and a CaxP level <= 65 mg2/dL2.
- For entry into the Treatment Phase, the subject must have had iPTH >= 300 pg/mL (determined by Nichols iPTH assay), a calcium level of 8.0 to 10.5 mg/dL, inclusive, and CaxP <= 65 mg2/dL2.
- Subject voluntarily signed and dated an informed consent, approved by an Institutional Review Board (IRB), after the nature of the study was explained and the subject had the opportunity to ask questions. The informed consent was signed before any study-specific procedures were performed or any medications were withheld.
- Additional criteria for HD subjects included the following: the subject was diagnosed with CKD Stage 5 and must have been on maintenance HD 3 times a week (TIW) for at least 2 months prior to the Screening Phase and was expected to remain on HD for the duration of the study.
- Additional criteria for PD subjects, included the following: the subject was diagnosed with CKD Stage 5 and must have been on continuous PD (either continuous cycling peritoneal dialysis [CCPD], continuous ambulatory peritoneal dialysis [CAPD], or a combination of the 2) 7 days per week for at least 2 months prior to the Screening Phase and was expected to remain on this PD regimen for the duration of the study.
Exclusion Criteria
- Subject had a history of an allergic reaction or significant sensitivity to drugs similar to the study drug.
- Subject received a partial parathyroidectomy within 1 year prior to the Screening Phase.
- Subject had acute renal failure within 3 months of the Screening Phase.
- Subject had chronic gastrointestinal disease, which in the investigator's opinion, may have resulted in clinically significant gastrointestinal malabsorption.
- Subject had taken aluminum-containing phosphate binders for > 3 weeks in the last 3 months prior to the Screening Phase, or required such medications for > 3 weeks in the study.
- Subject had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator.
- Subject had a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
- Subject had evidence of poor compliance with diet, medication or HD/PD that may have interfered, in the investigator's opinion, with adherence to the protocol.
- Subject had participated in any investigational drug or device study within 4 weeks prior to the Treatment Phase.
- Subject was taking calcitonin, maintenance IV or oral glucocorticoids, cinacalcet, bisphosphonates, vitamin D compounds (other than study drug), or other drugs that may have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
- Subject was known to be human immunodeficiency virus (HIV) positive.
- For any reason, subject was considered by the investigator to be an unsuitable candidate to receive Zemplar.
- Additional exclusion criteria for PD subjects, were: Subject had active peritonitis within 1 month prior to the Screening Phase; Subject had more than 1 episode of peritonitis within 4 months prior to the Screening Phase.
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: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Laura A Williams, M.D., MPH, 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 agosto de 2004
Fechas de registro del estudio
Enviado por primera vez
20 de septiembre de 2004
Primero enviado que cumplió con los criterios de control de calidad
21 de septiembre de 2004
Publicado por primera vez (Estimar)
22 de septiembre de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de enero de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
17 de enero de 2011
Última verificación
1 de julio de 2006
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M03-635
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 Zemplar Capsule
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Scott and White Hospital & ClinicAbbottDesconocidoDiabetes tipo 2 | Enfermedad Renal CrónicaEstados Unidos
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AbbottTerminadoInsuficiencia Renal CrónicaGrecia
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AbbVie (prior sponsor, Abbott)Massachusetts General HospitalTerminadoEnfermedad Renal Crónica | Hipertrofia del ventrículo izquierdoEstados Unidos, Australia, República Checa, Alemania, Italia, Polonia, Puerto Rico, Rumania, Federación Rusa, España, Taiwán, Reino Unido
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Dr. Reddy's Laboratories LimitedTerminado
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AbbVie (prior sponsor, Abbott)TerminadoEnfermedad Renal Crónica Etapa 3 y 4
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AbbottTerminadoEnfermedad Renal CrónicaPorcelana
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The University of Hong KongAbbottTerminado
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AbbottTerminadoHiperparatiroidismo secundario | Enfermedad Renal Crónica, Etapa 5Estados Unidos
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AbbottTerminadoInsuficiencia Renal Crónica | Hemodiálisis | Hiperparatiroidismo secundario | Hipercalcemia | Hormona paratiroideaPerú
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AbbottTerminadoHormona paratiroideaCroacia, Serbia