- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01656135
Reference Group Trial for The ONE Study
Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 13353
- Charité Campus Virchow-Klinikum
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Regensburg, Alemanha, 93053
- University Hospital Regensburg
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Nantes, França, 44093
- CHU de Nantes hotel-Dieu
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Milan, Itália, 20132
- Ospedale San Raffaele
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London, Reino Unido, SE1 9RT
- Guy's Hospital in affiliation with King's College London
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Oxford, Reino Unido, OX3 7LE
- Churchill Hospital in affiliation with the University of Oxford
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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:
Organ Donor:
A prospective donor is eligible for the research if all of the following inclusion criteria apply:
- Eligible for live kidney donation
- Aged at least 18 years
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study Subprojects
- Willing to provide personal and medical/biological data for the trial
- Signed and dated written informed consent.
In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
Organ Recipient:
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Aged at least 18 years
- Able to commence the immunosuppressive regimen at the protocol-specified time point
- Willing and able to participate in The ONE Study subprojects
- Signed and dated written informed consent.
Exclusion Criteria:
Organ Donor:
If a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA loci
- Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
Organ Recipient:
- Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft
- Known sensitivity to tacrolimus, mycophenolate, or corticosteroids
- Genetically identical to the prospective organ donor at the HLA loci
- PRA grade > 40% within 6 months prior to enrolment
- Previous treatment with any desensitisation procedure (with or without IVIg)
- Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
- Evidence of significant local or systemic infection
- HIV-positive, EBV-negative or suffering chronic viral hepatitis
- Significant liver disease, defined as persistently elevated AST and/or ALT levels >2 x ULN (Upper Limit of Normal range)
- Malignant or pre-malignant haematological conditions
- Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- Any condition which, in the judgement of the Investigator, would place the subject at undue risk
- Ongoing treatment with systemic immunosuppressive drugs at study entry
- Participation in another clinical trial during the study or within 28 days prior to planned study entry
- Female patients of child-bearing potential with a positive pregnancy test at enrolment
- Female patients who are breast-feeding
All female patients of child-bearing potential UNLESS:
- The patient is willing to maintain a highly effective method of birth control for the duration of the study
- The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the local Investigator)
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Reference Group
Basiliximab (Simulect®):
Prednisolone:
Steroid tapering should not proceed if graft rejection has occurred or if renal dysfunction is observed. Mycophenolate Mofetil (MMF, or biologic equivalent): Treatment with MMF should commence one day prior to transplantation (on Day -1) and should continue indefinitely, with a dose reduction after two weeks:
Tacrolimus (or biologic equivalent):
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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incidência de rejeição aguda confirmada por biópsia
Prazo: 60 semanas
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60 semanas
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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incidência de pacientes tratados para rejeição aguda subclínica
Prazo: 60 semanas
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60 semanas
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time to first acute rejection episode
Prazo: within 60 weeks
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within 60 weeks
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severity of acute rejection episodes
Prazo: within 60 weeks
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within 60 weeks
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total immunosuppressive burden
Prazo: 60 weeks
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60 weeks
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incidence of chronic graft dysfunction
Prazo: 60 weeks
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60 weeks
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incidence of graft loss through rejection
Prazo: 60 weeks
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60 weeks
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incidence of adverse drug reactions
Prazo: 60 weeks
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60 weeks
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incidence of major infections
Prazo: 60 weeks
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60 weeks
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incidence of neoplasia
Prazo: 60 weeks
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60 weeks
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Immune Monitoring (IM) assessment
Prazo: 60 weeks
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60 weeks
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Health Economics (HEC) assessment
Prazo: 60 weeks
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60 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Edward K. Geissler, Ph.D., University of Regensburg
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ONErgt11
- 260687 (Número de outro subsídio/financiamento: EU FP7 Programme)
- 2011-004301-24 (Número EudraCT)
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