SR121463B IN PATIENTS W/ SYNDROME INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION

SR121463B 用于抗利尿激素分泌不当综合征患者

• 批准号: 7608484
• 负责人: JOSEPH G VERBALIS
• 金额: $ 1.49万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608484
• 关键词: Clinical; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Evaluation; Funding; Grant; Hospitalization; Hypernatremia; Hyponatremia; Inappropriate ADH Syndrome; Institution; Instruction; Intake; Laboratories; Liquid substance; Monitor; Normal Range; Numbers; Pallister syndrome 1; Patients; Pharmaceutical Preparations; Rate; Recruitment Activity; Refractory; Research; Research Personnel; Resources; Safety; Schedule; Serum; Sodium; Source; Titrations; United States National Institutes of Health; Visit; Water consumption; base; day; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. To assess the long-term safety and tolerability SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH) This is a multicenter worldwide study. A minimum of 55 patients will be recruited to insure 45 patients with 6 months exposure. This number of patients may be revised in case of necessity. The eligible patients will receive four available daily doses of SR121463B (5 or 12.5 or 25 or 50 mg) based on their response for up to 343 days while they are under regular monitoring of laboratory and clinical parameters. The treatment aims to obtain a serum sodium within a normal range (135-145 mmol/L). The rate of correction of serum sodium should not exceed 8 mmoI/L/day over the first 2 days in order to avoid myelinolysis while correcting hyponatremia. In case of rapid correction of serum sodium, the Investigator should increase the fluid intake accordingly and perform additional assessment of serum sodium during the afternoon or evening if necessary (see Section 10.5 Safety instruction). The dose-adjustment will be according to the following rules. For the initial dose on Day 1, patients should be given 25 mg/day of SR121463B. From Day 2 to the end of the study, based on the new results of serum sodium, the Investigator will adjust at each visit the daily dose of SR121463B (decrease to 12.5 or 5 mg, discontinuation of the medication, increase to 50 mg, or no change) and/or the daily fluid intake. For patients with hyponatremia refractory to 50 mg/day of SR121463B for at least 28 days, the Investigator may consider to increase the dose after contacting the Trial Monitor. On Day 56, all patients with serum sodium > 135 mmol/L on the day of the visit who are still on study medication will discontinue the medication and have regular monitoring of laboratory and clinical parameters until the end of the study. Patients who re-develop hyponatremia (serum sodium < 135 mmol/L) on two consecutive visits, will re-start the medication with their last dose (see the proposed Study Flow Chart). Additional Visits for serum sodium assessment are permitted if necessary in order to adjust the treatment for reaching and maintaining normonatremia. Any effort should be made by the Investigator to find the minimum efficacious dose using down titration. If hypernatremia (serum sodium > 145 mmol/L) develops during the study, the drug should be temporarily discontinued and the patient should receive appropriate water intake. Patients who have a serum sodium > 135 mmol/L on two consecutive visits, 28 days apart after drug discontinuation, are considered "cured". These patients will discontinue the study and perform the evaluations scheduled for the last visit of the study (End of Study Visit). Hospitalization is not mandatory and its relevance is at the discretion of the Investigator. However, hospitalization is recommended (mainly for practical reasons of monitoring) from Day -1 to Day 3 (morning) in all patients.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此，可以在其他清晰的条目中表示。列出的机构是 对于中心，这不一定是调查员的机构。 评估长期安全性和耐受性 不适当抗利尿激素分泌（SIADH）的综合征患者的SR121463B 这是一项全球多中心研究。至少将招募55例患者，以确保45例患者6个月的暴露。如果需要，可能会修订此数量的患者。符合条件的患者将根据他们的反应长达343天，在经常监测实验室和临床参数的情况下，根据他们的反应长达343天，将获得四次可用剂量的SR121463B（5或12.5或25或50 mg）。 该治疗旨在在正常范围内获得血清钠（135-145 mmol/L）。在校正低钠血症的同时避免骨髓溶解，血清钠的校正率不得超过8 mmoi/l/天。如果需要快速校正血清钠，则研究者应相应地增加液体摄入量，并在必要时在下午或晚上对血清钠进行额外评估（请参阅第10.5节安全说明）。 剂量调整将根据以下规则。对于第1天的初始剂量，应为患者提供25 mg/天的SR121463B。从第2天到研究结束，根据血清钠的新结果，研究人员将在每次访问时调整SR121463B的每日剂量（降低至12.5或5 mg，停用药物，增加到50 mg，或增加到50 mg或无需更改）和/或每日液体摄入量。对于低钠血症患者的SR121463B至少28天的患者，研究人员可以考虑在与试验监测仪联系后增加剂量。 在第56天，所有仍在研究药物的访问当天的血清钠> 135 mmol/L的患者将停止使用药物，并定期监测实验室和临床参数，直到研究结束。重新发育低钠血症（血清钠<135 mmol/L）的患者将连续两次就诊，将重新开始使用最后剂量（请参阅拟议的研究流程图）。 如有必要，允许进行血清钠评估的额外访问，以调整到达和维持正常血症的治疗方法。研究人员应尽一切努力使用滴定滴定的最低有效剂量。 如果在研究期间出现高钠血症（血清钠> 145 mmol/L），则应暂时停用该药物，并应接受适当的水摄入量。 在两次访问中，血清钠> 135 mmol/L的患者被认为是“治愈”的。这些患者将停止研究，并进行安排的最后一次访问（研究访问）的评估。 住院不是强制性的，其相关性是由调查人员酌情决定的。但是，所有患者的第1天到第3天（早上），建议住院（主要是出于实际原因）。