ACTRN12623000732684撤回1 期
A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Have an estimated glomerular filtration rate (eGFR) greater than or equal to 20 and less than or equal to 60 millilites per minute per body surface area.
- •- Evidence of increased albuminuria for at least 3 months prior to Day 1
- •- Urinary albumin creatinine ratio greater than or equal to 30 mg/mmol, and/or urinary protein creatinine ratio greater than or equal to 50 milligrams per millimol
- •- If requiring treatment with an angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT2) inhibitor, must be on a stable dose for at least the 4 weeks prior to Day 1, with the intent to remain on that dose during the study period.
排除标准
- •- Have had a prior renal transplant, or likely to require renal transplant during the study period.
- •- Have Autosomal Dominant Polycystic Kidney Disease (ADPKD) or documented inflammatory conditions, including lupus nephritis, and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)
- •- Uncontrolled arterial hypertension defined as average of 3 systolic blood pressure readings of greater than or equal to 170 millimetre of mercury (mmHg) or an average of 3 diastolic blood pressure greater than or equal to 110 mmHg,
- •- Peripheral vascular disease, chronic ulcers, or significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis.
- •- Surgery within the 3 months prior to Day 1 or planned during the study period.
- •- Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 milligrams per day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of screening or planned during the study period.
- •- Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) or evidence of hepatic disease as determined by history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt.
- •- Haemoglobin less than 80 grams per litre, platelets less than 90 x 10^9 per litre, or neutrophil count less than 1.4 x 10^9 per litre.
研究者
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