Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
30 de junio de 2015 actualizado por: Veloxis Pharmaceuticals
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
Fase
- Fase 2
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, 92123
- Clinical Investigative Site 000015
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San Francisco, California, Estados Unidos, 94115
- Clinical Investigative Site 000012
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Clinical Investigative Site 00004
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Florida
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Tampa, Florida, Estados Unidos, 33606
- Clinical Investigative Site 000002
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0293
- Clinical Investigative Site 000005
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Clinical Investigative Site 000009
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New Jersey
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Livingston, New Jersey, Estados Unidos, 07039
- Clinical Investigative Site 000010
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New York
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Buffalo, New York, Estados Unidos, 14215
- Clinical Investigative Site 000011
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New York, New York, Estados Unidos, 10016
- Clinical Investigative Site 00006
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Ohio
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Cleveland, Ohio, Estados Unidos, 44095
- Clinical Investigative Site 00008
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Clinical Investigative Site 00003
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Clinical Investigative Site 000013
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- Clinical Investigative Site 00001
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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 a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria
- Give written consent
- Male and female subjects between the ages of 18 and 70 years, inclusive
- Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
- WOCBP must have a negative pregnancy test
- Must have negative cross-match test and be ABO-compatible
- Must be able to swallow tablets and capsules
Exclusion criteria
- Recipients of any previous nonrenal or concurrent transplant
- Have panel reactive antibody >50%
- Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
- History of alcohol abuse with less than 6 months of sobriety
- History of recreational drug abuse with less than 6 months of documented abstinence
- Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
- WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
- Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
- Oral temperature (prior to study drug dosing) of 38.0ºC or higher
- CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
- Known hereditary immunodeficiency
- Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
- Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Clinically symptomatic CHF or documented EJF of less than 45%
- Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
- Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
- Laboratory variables that are abnormal (outside laboratory reference range) and CS
- Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
- Subjects who have had primary focal segmental glomerulosclerosis
- Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
Otros nombres:
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Comparador activo: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
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Tacrolimus
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 1 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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1 days
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 14 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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14 days
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 28 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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28 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 1 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 14 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 28 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 1 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 14 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 28 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 14 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Periodo de tiempo: 28 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Periodo de tiempo: 14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Periodo de tiempo: 28 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
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28 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
Periodo de tiempo: 14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
Periodo de tiempo: 28 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
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28 days
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Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
Periodo de tiempo: 30 days
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The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
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30 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: William Polvino, MD, Veloxis Pharmaceuticals
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 noviembre de 2012
Finalización primaria (Actual)
1 de marzo de 2013
Finalización del estudio (Actual)
1 de mayo de 2013
Fechas de registro del estudio
Enviado por primera vez
14 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2012
Publicado por primera vez (Estimar)
16 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
30 de junio de 2015
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LCP-Tacro 2019
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. .