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Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

19 de janeiro de 2015 atualizado por: Novartis Pharmaceuticals

Presentation of Renal Function in Liver Transplant Recipients With Certican Therapy: PROTECT Study A Twelve-month, Multicenter, Randomized, Open-label Study of Safety, Tolerability and Efficacy of Certican-based Regimen Versus Calcineurin Inhibitor-based Regimen in de Novo Liver Transplant Recipients

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

276

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
        • Novartis Investigative Site
      • Essen, Alemanha, 45147
        • Novartis Investigative Site
      • Frankfurt, Alemanha, 60590
        • Novartis Investigative Site
      • Hamburg, Alemanha, 20246
        • Novartis Investigative Site
      • Hannover, Alemanha, 30625
        • Novartis Investigative Site
      • Heidelberg, Alemanha, 69120
        • Novartis Investigative Site
      • Jena, Alemanha, 07740
        • Novartis Investigative Site
      • Muenster, Alemanha, 48149
        • Novartis Investigative Site
      • Regensburg, Alemanha, 93053
        • Novartis Investigative Site
      • Tübingen, Alemanha, 72076
        • Novartis Investigative Site
  • Holanda
      • Groningen, Holanda, 9713 GZ
        • Novartis Investigative Site
      • Rotterdam, Holanda, 3015 CE
        • Novartis Investigative Site
  • Suíça
      • Genève, Suíça, 1211
        • Novartis Investigative Site
      • Zurich, Suíça, 8091
        • Novartis Investigative Site
  • Áustria
      • Innsbruck, Áustria, A-6020
        • Novartis Investigative Site
      • Wien, Áustria, A-1090
        • Novartis Investigative Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Males or females 18 - 70 years old
  • Liver transplant recipient (living or deceased donor)
  • Patients in whom an allograft biopsy will not be contraindicated

Exclusion Criteria:

  • Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
  • HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
  • HIV positive patients
  • Patients who are breast feeding
  • Patients with a current severe systemic infection
  • Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
  • Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
  • Patients that have received Simulect prior to this study.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
Experimental: Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
Medicamento: basiliximab
All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
Outros nomes:
  • simulect
Medicamento: CNI
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Comparador Ativo: Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
Medicamento: basiliximab
All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
Outros nomes:
  • simulect
Medicamento: CNI
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Medicamento: everolimus
Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.
Outros nomes:
  • Certican

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Calculated Glomerular Filtration Rate (cGFR)
Prazo: Month 11
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
Month 11

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of Efficacy Failure
Prazo: Month 11
Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).
Month 11
Incidence of the Need for a Change in the Immunosuppressive Regimen
Prazo: Month 11
The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).
Month 11
Incidence of Renal Deterioration
Prazo: Baseline, Month 11
Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.
Baseline, Month 11
Renal Function (cGFR)
Prazo: Month 5
This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
Month 5
Incidence of Treated BPAR
Prazo: Month 11
The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).
Month 11
Patient and Graft Survival
Prazo: Month 11
Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.
Month 11
Hepatitis C Virus (HCV) Replication in HCV-positive Patients
Prazo: Baseline, Month 5
HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).
Baseline, Month 5
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Prazo: From randomization to Month 11
Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
From randomization to Month 11
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Prazo: Month 12 to Month 59 post-baseline
Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
Month 12 to Month 59 post-baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2006

Conclusão Primária (Real)

1 de janeiro de 2013

Conclusão do estudo (Real)

1 de janeiro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de setembro de 2006

Primeira postagem (Estimativa)

19 de setembro de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

6 de fevereiro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de janeiro de 2015

Última verificação

1 de janeiro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CRAD001HDE10
  • 2005-002920-32

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 .

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