Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
30 de junho de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
36
Estágio
- Fase 2
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
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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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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
- 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
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
Outros nomes:
|
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Comparador Ativo: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
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Tacrolimus
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Prazo: 1 days
|
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
Prazo: 14 days
|
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
Prazo: 28 days
|
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
Prazo: 1 days
|
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
Prazo: 14 days
|
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
Prazo: 28 days
|
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
Prazo: 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
Prazo: 14 days
|
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
Prazo: 28 days
|
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
Prazo: 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
Prazo: 28 days
|
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Prazo: 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.
Prazo: 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.
Prazo: 14 days
|
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.
Prazo: 28 days
|
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.
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: William Polvino, MD, Veloxis 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 novembro de 2012
Conclusão Primária (Real)
1 de março de 2013
Conclusão do estudo (Real)
1 de maio de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
14 de agosto de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2012
Primeira postagem (Estimativa)
16 de agosto de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de julho de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de junho de 2015
Última verificação
1 de junho de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LCP-Tacro 2019
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