EUCTR2013-003354-24-NL进行中（未招募）不适用
Influence of exogenous growth hormone administration on circulating levels of Klotho in healthy and CKD subjects
Vrij Universiteit Medical Center0 个研究点开始时间: 2014年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Healthy patients without CKD, or patients with CKD stage III.
- •-Patients = 18 years and < 65 years old.
- •-Providing informed consent.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients who, in the opinion of the study investigator may present a safety risk.
- •-Patients who are unlikely to adequately comply with the trial’s procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or non-compliance).
- •-Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. growth hormone suppletion, thyroid hormone suppletion, use of estrogens, corticosteroids, androgens or anabole steroids, insulin).
- •-Patients taking other experimental (i.e., non marketed) therapies within a month before preceding screening.
- •-Patients with any pituitary disease.
- •-Women who are pregnant, breastfeeding, intend to become pregnant, or not using or willing to use adequate contraception.
- •-Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking the investigational product.
- •-Known growth hormone deficiency.
- •-History of any malignancy, or active current malignancy.
- •-Active intracranial tumours.
- •-BMI > 30.
- •-History of respiratory disorders or obstructive sleep apnea syndrome (OSAS).
- •-Critical illness as defined by the need for respiratory or circulatory support (e.g., in an intensive care unit).
- •-Patients with thyroidal disease.
- •-Treatment with immunosuppressive agents.
- •-Patients with active vasculitis.
- •-Patients with heart failure or a history of heart failure.
- •-Severe hepatic disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal).
- •-Severe chronic systemic infections or inflammatory disease.
- •-Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg two times measured).
- •-Active respiratory infection.
- •-Patients with diabetes.
- •-Patients with signs of malnutrition.
- •-Patients with autosomal dominant polycystic kidney disease (ADPKD).
- •-Patients with a single kidney.
- •-Known or suspected allergy to trial product(s) or related products
研究者
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