Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
28 de fevereiro de 2014 atualizado por: AbbVie (prior sponsor, Abbott)
Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Federation
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia.
Planned therapy will be six months.
Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study.
Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.
Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).
Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.
The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.
Tipo de estudo
Observacional
Inscrição (Real)
86
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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Almetyevsk, Federação Russa, 423450
- Site Reference ID/Investigator# 57348
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Cheboksary, Federação Russa, 428018
- Site Reference ID/Investigator# 57347
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Chelyabinsk, Federação Russa, 454076
- Site Reference ID/Investigator# 58347
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Iakutsk, Federação Russa, 677019
- Site Reference ID/Investigator# 67404
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Irkutsk, Federação Russa, 664079 RF
- Site Reference ID/Investigator# 57344
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Kazan, Federação Russa, 420045
- Site Reference ID/Investigator# 57346
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Moscow, Federação Russa, 125284
- Site Reference ID/Investigator# 58356
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Moscow, Federação Russa, 127015
- Site Reference ID/Investigator# 58348
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Novosibirsk, Federação Russa, 630120
- Site Reference ID/Investigator# 57342
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Orenburg, Federação Russa, 460040
- Site Reference ID/Investigator# 57364
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Samara, Federação Russa, 443095
- Site Reference ID/Investigator# 69687
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St. Petersburg, Federação Russa, 191104
- Site Reference ID/Investigator# 57363
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Ulan-Ude, Federação Russa, 670031
- Site Reference ID/Investigator# 69688
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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 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Hemodialysis centers
Descrição
Inclusion Criteria:
- Age 18-65 years
- Chronic Kidney Disease stage 5 receiving hemodialysis
- Authorization (Consent) for Use/Disclosure of Data signed by the patient
- Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
- Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL
Exclusion Criteria:
- Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy
- Any experimental drug within the period of 30 days before the inclusion into the program
- Screening Ca x P > 65 mg˄2/dL˄2
- Screening normalized serum total calcium > 10.2 mg/dL
- Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy
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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Stage 5 Chronic Kidney Disease
Planned for Zemplar administration due to secondary hyperparathyroidism
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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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The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study
Prazo: 6 months
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The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
Prazo: 6 months
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The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
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6 months
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Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
Prazo: 6 months
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The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study
Prazo: 6 months
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The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
Prazo: 6 months
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The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
Prazo: 6 months
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The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
Prazo: 6 months
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The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
Prazo: 6 months
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The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks. |
6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Andrey Strugovshchikov, MD, AbbVie LLC
Publicações e links úteis
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Links úteis
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 julho de 2011
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
22 de julho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2011
Primeira postagem (Estimativa)
25 de julho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de março de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de fevereiro de 2014
Última verificação
1 de fevereiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P12-838
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