2023-503894-39-00已完成Phase III and phase IV (Integrated)
Prospective Randomized trial of Everolimus replacing MMF/MP Acid by the RECOVAC consortium to increase VACcine response in kidney transplant patients
Universitair Medisch Centrum Groningen, Universitair Medisch Centrum Groningen7 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- The neutralizing antibody titer against the Omicron XBB.1.5 strain 28 days after monovalent Omicron XBB.1.5. COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.
研究概览
简要总结
To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titers
研究设计
- 分配方式
- Randomized
- 主要目的
- Prepare-i Vac
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •≥6 months after kidney transplantation
- •Eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous COVID-19 vaccinations as part of the primary COVID-19 immunisation)
- •Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- •Willing to adhere to the protocol and be available during the study period
- •Maintenance immunosuppressive therapy consisting of either triple or dual therapy including MMF/MPA with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA) and a CNI
排除标准
- •Multi-organ transplant recipient
- •Simultaneous participation in another interventional study that will likely influence the study outcomes
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s)
- •Active COVID-19 disease
- •Additional for part 2: Active varicella or herpes zoster disease
- •Active malignancy, except non-melanoma skin cancer
- •Inherited immune deficiency
- •Infection with Human Immunodeficiency Virus (HIV)
- •Administration of T-cell, B-cell, or plasma cell depleting antibodies during the last 6 months
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- •Previous CNI trough levels not sufficient according to the discretion of the treating physician
- •Subjects with severe systemic infections, current or within the two weeks prior to randomisation
- •More than two previous kidney transplantations
- •Calculated level of panel reactive antibodies prior to last transplantation above 85%
- •Evidence of DSAs
- •Signs of acute rejection during the preceding year
- •Subjects with severe restrictive or obstructive pulmonary disorders
- •Subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
- •Subjects with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit
- •Proteinuria > 1 gram/day at last outpatient clinic visit
- •Contra-indications for use of everolimus according to the opinion of the treating physician
- •Additional for part 2: Herpes zoster vaccination with the live attenuated vaccine (Zostavax) or varicella vaccination (Provarivax) during the conduct of the study
- •Additional for part 2: Previous herpes zoster vaccination with the RZV
结局指标
主要结局
The neutralizing antibody titer against the Omicron XBB.1.5 strain 28 days after monovalent Omicron XBB.1.5. COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.
The neutralizing antibody titer against the Omicron XBB.1.5 strain 28 days after monovalent Omicron XBB.1.5. COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.
次要结局
- SARS-CoV-2 specific anti-S1 antibody level at 28 days after COVID-19 vaccination
- Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination
- SARS-CoV-2 specific T-cell response at 28 days after COVID-19 vaccination
- Varicella zoster specific T-cell response at 28 days after 2nd herpes zoster vaccination
- Incidence of treated acute rejection
- Change in estimated glomerular filtration rate and proteinuria during the study
- Incidence of serious adverse events throughout the study
- Incidence of adverse events of special interest throughout the study
- Incidence of dnDSAs at V7, or when not participating in second part of the study at V5.
- Incidence of solicited adverse events of COVID-19 vaccination during 7 days after vaccination
- Incidence of solicited adverse events of herpes zoster vaccination during 7 days after each vaccination
研究者
Project leader
Scientific
Universtity Medical Center
研究点 (7)
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