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- Ensaio 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
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Jeonju, Republica da Coréia
- Chonbuk National University Hospital
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Seoul, Republica da Coréia
- Samsung Medical Center
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Seoul, Republica da Coréia
- Gangnam Severance Hospital
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Suwon, Republica da Coréia
- Ajou University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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
Outros nomes:
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Comparador Ativo: 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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
renal graft function
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
incidence of treatment failure
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes antibacterianos
- Antibióticos, Antineoplásicos
- Agentes Antituberculares
- Antibióticos, Antituberculose
- Inibidores de Calcineurina
- Tacrolimo
- Ácido micofenólico
Outros números de identificação do estudo
- 062KTP14-1C
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Tacrolimus(reduced), Mycophenolate mofetil(standard)
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National Institute of Allergy and Infectious Diseases...Johns Hopkins University; PPDAtivo, não recrutandoReceptores de Transplante de Fígado | Receptores de Transplante RenalEstados Unidos