EUCTR2013-000192-33-IT进行中（未招募）不适用
A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in HemodialysisSubjects With Secondary Hyperparathyroidism
KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)0 个研究点目标入组 600 人开始时间: 2013年5月8日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has provided informed consent.
- •- Subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •- Subject is 18 years of age or older.
- •- Female subject must be willing to use highly effective contraception during the study and for 3 months after the last dose of investigational product (unless postmenopausal or surgically sterilized).
- •- Male subject must be willing to use highly effective contraception during the
- •- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis with a delivered Kt/V = 1.2 or urea reduction ratio (URR) = 65% within 4 weeks prior to screening laboratory assessments.
- •- Dialysate calcium concentration must be = 2.5 mEq/L and stable for at least 3 months prior to screening laboratory assessments, and must remain = 2.5 mEq/L for the duration of the study.
- •- Subject must have SHPT as defined by having 2 consecutive central laboratory screening predialysis plasma PTH values > 600 pg/mL, measured on separate days within 4 weeks prior to randomization.
- •For a subject currently receiving vitamin D sterols, the vitamin D dose must have been constant with no change for a minimum of 4 weeks prior to screening laboratory assessments and until randomization.
- •- Subject must have 2 consecutive screening predialysis serum cCa laboratory values measured on separate days within 4 weeks prior to randomization, and the results on both days must be = 8.3 mg/dL.
- •- A subject receiving calcium supplements must be on a stable dose for at least 2 weeks prior to screening laboratory assessments and until randomization.
- •- A subject receiving phosphate binders must be on a stable dose for at least 2 weeks prior to screening laboratory assessments and dose should remain stable throughout the study except as noted in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- •- Currently receiving other investigational procedures while participating in this study are excluded.
- •- Subject has participated in a prior clinical trial of AMG 416 (also known as KAI-4169).
- •- Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments.
- •- Subject has known sensitivity to any of the products or components of either cinacalcet or AMG 416 to be administered during dosing.
- •- Subject has entered this study previously.
- •- Anticipated or scheduled parathyroidectomy during the study period.
- •- Subject has received a parathyroidectomy within 6 months prior to dosing.
- •- Anticipated or scheduled kidney transplant during the study period.
- •- Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
- •- Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ).
- •- Subject is pregnant or nursing.
- •- Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
- •- Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- •- Subject has clinically significant abnormalities on prestudy clinical examination or central laboratory tests during the 4 weeks prior to randomization according to the Investigator including but not limited to the following:
- •serum albumin < 2.5 g/dL
- •serum magnesium < 1.5 mg/dL
- •serum transaminase (alanine transaminase [ALT] or Serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 2.5 times the upper limit of normal (ULN) at screening
- •- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator’s knowledge.
- •- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. This includes a subject who previously received cinacalcet, and in the opinion of the Investigator, is not a good candidate for future cinacalcet treatment.
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