EUCTR2012-001966-14-ES进行中（未招募）1 期
A Cross-sectional Study of Renal Function in Treatment-naïve, Young Male Patients with Fabry Disease - FABRY-MAP
Genzyme, a Sanofi Company0 个研究点目标入组 39 人开始时间: 2012年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
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
- Male
入选标准
- •A patient must meet all of the following criteria to be eligible for this study.
- •1. The patient and/or their parent/legal guardian is willing and able to provide signed informed consent. If the patient is below the age of consent per local guidelines, he is willing to provide assent, if
- •deemed able to do so.
- •2. The patient must have a confirmed diagnosis of Fabry disease as documented by leukocyte ?-galactosidase A (?GAL) of <4 mol/hr/mg leukocyte (preferred assay; results from a central
- •laboratory). If the leukocyte ?GAL activity assay is difficult to obtain, the patient may be enrolled based on documented plasma ?GAL <1.5 nmol/hr/mL (results from a central laboratory), with the
- •agreement of the Genzyme Medical Monitor.
- •3. The patient must be male and ?5 and ?25 years of age at screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient who meets any of the following criteria will be excluded from this study.
- •1. Patient has received prior treatment with enzyme replacement therapy (ERT) or oral pharmacological chaperone therapy for Fabry disease.
- •2. Patient has received an investigational drug within 30 days of the screening visit.
- •3. Patient is receiving any of the following medications and is clinically unable or unwilling to temporarily discontinue treatment with these medications for the indicated washout period prior to
- •the renal function assessments until completion of these assessments:
- •? Angiotensin converting enzyme inhibitors or angiotensin receptor blockers (6 week washout);
- •? Non-steroidal anti-inflammatory drugs (3 day washout).
- •NOTE: Patients who are on chronic dialysis or have had a kidney transplant will not be required to discontinue the above medications because renal function assessments will not be performed in these
- •4. Patient has any contraindication mentioned in the labeling of iohexol. NOTE: patients with an eGFR <30 mL/min/1.73m2 and patients who are on chronic dialysis or have had a kidney transplant may be enrolled irrespective of any contraindication to iohexol because iGFR will not be measured in these patients.
- •5. Patient has any medical condition or extenuating circumstance which, in the opinion of the Investigator, could interfere with the patient?s ability to complete all study procedures, or with the
- •interpretation of study results (e.g., diabetes mellitus).
- •6. The patient and/or their parent or legal guardian, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
研究者
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