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- Ensayo clínico NCT03968588
Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation
Comparative Clinical Study of Reduced Dose of Tacrolimus and Standard Dose of Mycophenolate Mofetil vs. Conventional Dose of Tacrolimus and Reduced Dose of Mycophenolate Mofetil in De Novo Renal Transplant Recipients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group. For six months study period, graft function, the incidence of efficacy failure and adverse events were compared.
The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group: The study group (reduced-dose tacrolimus + standard-dose MMF) or the control group (standard-dose tacrolimus + reduced-dose MMF). Restricted block randomization was applied to this study and both the enrolled subjects and care providers were blinded until randomization was done. A difference in the mean estimated glomerular filtration rates (eGFR) of 16 mL/min/1.73m2 was considered a clinically meaningful margin of non-inferiority. A sample size of 108 for both groups was calculated for the primary endpoint by assuming a significance level of 0.025 with a power of at least 95% and adjusted for a potential dropout rate of 20%.
The primary efficacy endpoint was the renal graft function assessed with eGFR by MDRD formula at 6 months post-transplant. The secondary endpoints included (1) the incidence of treatment failure that included biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss to follow-up until 6 months post-transplant; (2) recipients and grafts' survival rates; (3) 24-hour urine proteinuria and creatinine clearance at 6 months post-transplant. Recipients with clinical findings suggestive of acute rejection underwent biopsies before initiation or within 48 hours of anti-rejection therapy and biopsy specimens were graded according to Banff Classification criteria.
Safety endpoints included (1) all adverse event defined as any medical occurrence including worsening of a preexisting medical condition; (2) opportunistic infections; (3) malignancies; (4) abnormal laboratory findings; and (5) any abnormal physical findings or vital signs. Severe adverse events were defined as any adverse events with undesirable signs, symptoms, or medical conditions that met any one of the following criteria: 1) was fatal or life-threatening, 2) resulted in persistent or significant disability/incapacity, 3) required hospitalization or the prolongation of existing hospitalization, 4) was a congenital anomaly/birth defect, or 5) was an important medical event that might deteriorate the patient and require medical or surgical intervention to prevent one of the other outcomes listed above.18 All adverse events were coding using WHOART 2009 version.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Jeonju, Corea, república de
- Chonbuk National University Hospital
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Seoul, Corea, república de
- Samsung Medical Center
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Seoul, Corea, república de
- Gangnam Severance Hospital
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Suwon, Corea, república de
- Ajou University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Recipients (aged 20-65) of a single (first or second) renal allograft from living or deceased donor.
Exclusion Criteria:
- comprised of recipients with multiple organ transplants
- double kidney transplant or organs donated after cardiac death
- recipients previously organ transplanted except kidney
- ABO-incompatible transplants
- recipients with antibodies against the human leukocyte antigens of the donor organ
- history of malignancy in the previous 5 years (except successfully treated localized non-melanoma skin cancer and thyroid cancer)
- leukocyte counts of less than 2,500 per μL, or neutrophils less than 1,500 per μL, or platelets less than 50,000 per μL
- evidence of active systemic infection requiring the use of antibiotics, human immunodeficiency virus infection, or chronic active hepatitis B or C
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: reduced-dose tacrolimus + standard-dose MMF
Tacrolimus dose was individually adjusted with a target trough blood level of between 3ng/mL and 8ng/mL throughout the study period (6 months after transplantation).
MMF started within 72 hours after transplantation and the dose of MMF was 1.5~2.0g
per day.
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tacrolimus target trough blood level: 3~8ng/mL MMF dose: 1.5~2g/d
Otros nombres:
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Comparador activo: standard-dose tacrolimus + reduced-dose MMF
Control group, target trough blood level was between 5ng/mL and 15ng/mL throughout the study period.
MMF dose was 0.5~1g per day and MMF started within 72 hours after transplantation.
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tacrolimus target trough blood level: 5~15ng/mL MMF dose: 0.5~1g/d
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
renal graft function
Periodo de tiempo: 6 months post-transplant
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assessed with eGFR by MDRD formula
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6 months post-transplant
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
incidence of treatment failure
Periodo de tiempo: 6 months post-transplant
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biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss
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6 months post-transplant
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recipients and grafts' survival rates
Periodo de tiempo: 6 months post-transplant
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recipients and grafts' survival rates
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6 months post-transplant
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24-hour urine proteinuria and creatinine clearance
Periodo de tiempo: 6 months post-transplant
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24-hour urine proteinuria and creatinine clearance
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6 months post-transplant
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chang-Kwon Oh, M.D, Department of surgery, Ajou University School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antibacterianos
- Antibióticos, Antineoplásicos
- Agentes antituberculosos
- Antibióticos, Antituberculosos
- Inhibidores de calcineurina
- Tacrolimus
- Ácido micofenólico
Otros números de identificación del estudio
- 062KTP14-1C
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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 Tacrolimus(reduced), Mycophenolate mofetil(standard)
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