Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
26 de março de 2012 atualizado por: Abbott
A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.
Visão geral do estudo
Status
Concluído
Descrição detalhada
The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.
The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.
A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:
- 40% reduction in the base iPTH level is achieved, and/or;
- serum iParathormone level < 300 pg/mL.
Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.
Tipo de estudo
Observacional
Inscrição (Real)
237
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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Athens, Grécia, 11526
- Site Reference ID/Investigator# 32055
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Athens, Grécia, 11528
- Site Reference ID/Investigator# 32050
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Athens, Grécia, 11528
- Site Reference ID/Investigator# 32051
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Athens, Grécia, 17237
- Site Reference ID/Investigator# 32049
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Athens, Grécia
- Site Reference ID/Investigator# 5283
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Chalkida, Grécia, 34100
- Site Reference ID/Investigator# 32056
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Chania, Grécia, 73100
- Site Reference ID/Investigator# 32057
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Drama, Grécia, 66100
- Site Reference ID/Investigator# 32058
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Holargos, Grécia, 15562
- Site Reference ID/Investigator# 32077
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Katerini, Grécia, 60100
- Site Reference ID/Investigator# 32076
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Kavala, Grécia, 65201
- Site Reference ID/Investigator# 32059
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Komotini, Grécia, 69100
- Site Reference ID/Investigator# 32053
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Lamia, Grécia, 35100
- Site Reference ID/Investigator# 32060
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Lefkada, Grécia, 31100
- Site Reference ID/Investigator# 32061
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Livadia, Grécia, 32100
- Site Reference ID/Investigator# 32062
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Pireus, Grécia
- Site Reference ID/Investigator# 32048
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Preveza, Grécia, 48100
- Site Reference ID/Investigator# 32054
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Ptolemaida, Grécia, 50200
- Site Reference ID/Investigator# 32063
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Volos, Grécia, 38222
- Site Reference ID/Investigator# 32075
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics
Descrição
Inclusion Criteria:
- Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
- Subject is receiving chronic hemodialysis.
- Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
- Subject has provided their informed consent to participate.
Exclusion Criteria:
- Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
- Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
- Subject has participated in clinical study within the last month.
- Zemplar is contraindicated according to the Summary of Product Characteristics.
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
Coortes e Intervenções
Grupo / Coorte |
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Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Prazo: Baseline to Month 24 Visit
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The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
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Baseline to Month 24 Visit
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Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
Prazo: Baseline to Month 24 Visit
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The mean (average) number of days hospitalized per participant for those hospitalized during the study.
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Baseline to Month 24 Visit
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
Prazo: Baseline to Month 24 Visit
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Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Hypercalcemia
Prazo: Baseline to Month 24 Visit
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The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Hyperphosphatemia
Prazo: Baseline to Month 24 Visit
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The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
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Baseline to Month 24 Visit
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The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
Prazo: Baseline to Month 24 Visit
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The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.
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Baseline to Month 24 Visit
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To Estimate the Incidence of (S)AEs/(S)ADRs
Prazo: Baseline to Month 24 Visit
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The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized.
Adverse events include any events reported regardless of whether or not they were considered related to the study drug.
Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected.
For additional details see the Reported Adverse Events section.
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Baseline to Month 24 Visit
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Konstantinos Xynos, MD, Abbott Laboratories Hellas S.A.
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 dezembro de 2006
Conclusão Primária (Real)
1 de fevereiro de 2011
Conclusão do estudo (Real)
1 de fevereiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
27 de fevereiro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2010
Primeira postagem (Estimativa)
5 de março de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
27 de março de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de março de 2012
Última verificação
1 de março de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P06-120
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