NL-OMON40366已完成2 期
Influence of exogenous growth hormone administration on circulating levels of Klotho in healthy and chronic kidney disease subjects - Klotho & Growth hormone
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with CKD stage III, control group: patients without CKD.
- •- Patients * 18 years and < 65 years old.
- •- Providing informed consent.
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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