NL-OMON51071已完成4 期
The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant - The RECOVAC IR study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. All patients should be eligible for COVID-19 vaccination as described by the
- •instructions of the manufacturer.
- •2. Age of 18 years or older
- •3. Capable of understanding the purpose and risks of the study, fully informed
- •and given written informed consent (signed informed consent form has been
- •- CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI
- •- Hemodialysis, or peritoneal dialysis
- •- Kidney transplant recipient at least 6 weeks after transplantation
- •- Partner, sibling, or other family member of participating patient with eGFR
- •> 45 ml/min * 1,73 m2
排除标准
- •-History of severe adverse reaction associated with a vaccine and/or severe
- •allergic reaction (eg, anaphylaxis) toany component of the study
- •intervention(s).
- •-Multi-organ recipients
- •-Previous or active COVID-19 disease
- •-Active (haematological) malignancy
- •-Inherited immune deficiency
- •-Infection with Human Immunodeficency Virus (HIV)
- •-Bleeding diathesis or condition associated with prolonged bleeding that would,
- •in the opinion of the investigator, contraindicate intramuscular injection.
研究者
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