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- Ensaio Clínico NCT01818687
Safety and Tolerability Study of MCI-196
A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Chronic Kidney Disease Stages 3b to 5 and With Hyperphosphataemia Not on Dialysis
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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London, Reino Unido
- Investigational Site
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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:
- Children aged 2 years to <18 years with CKD stages 3b to 5, not on dialysis (stage 3b is defined as a glomerular filtration rate below 45 mL/min/1.73 m²).
- The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus (P) levels above the age-related upper limit of normal (ULN) (Kidney Disease Outcomes Quality Initiative [KDOQI] Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008).
- The subject is on a stable P diet at baseline (as judged by the Investigator).
Inclusion criteria for subjects not currently treated with phosphate binders:
- The subject, with serum P not controlled despite being on an appropriate P diet, must demonstrate serum P levels >1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the screening period. Such subjects do not require wash-out and should proceed to baseline for the next visit if additional screening visits are not required.
Baseline inclusion criteria for subjects treated with phosphate binders:
- The subject must enter the wash-out period, during which he/she must demonstrate serum P levels >1.5 SD above the KDOQI 2008 age-related mean value at any time during the wash-out period (after stopping phosphate binders), and;
- The subject must demonstrate an increase in serum P levels by at least 10% above the pre wash-out level (after stopping phosphate binders).
Note: should a subject fail to meet any of the above criteria, the subject is permitted to be re-screened once after an interval of at least three months.
Exclusion Criteria:
- The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
- The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery)
- The subject cannot stop treatment (prescription or over the-counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril
- The subject is receiving immunosuppressant treatment for any medical condition at the baseline visit or is expected to receive such treatment during the course of the study
- The subject is considered as unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e, serum P and Ca levels]
Exclusion criteria for subjects treated with phosphate binders:
- The subject was treated with a combination of two or more phosphate binders within one month prior to screening
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- 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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Experimental: MCI-196 (dose flexível)
MCI-196 BSA eq 3g, 6g, 9g, 12g ou 15g
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equivalente de área de superfície corporal (BSaeq) 3 g/dia, 6 g/dia, 9 g/dia, 12 g/dia ou 15 g/dia
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.
Prazo: 17 weeks
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17 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Incidence of TEAEs of hypercalcaemia and hypocalcaemia
Prazo: 17 weeks
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17 weeks
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Laboratory safety assessments
Prazo: 17 weeks
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17 weeks
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Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCI-196-E16
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 colestilano
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Mitsubishi Tanabe Pharma CorporationConcluídoDislipidemia | Doença Renal Crônica | Hiperfosfatemia | DiálisePolônia, Ucrânia, Sérvia, Federação Russa, Hungria, Malásia, Itália, Macedônia, Antiga República Iugoslava da