NCT04837092已完成1 期
A Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of FR104, a Novel Antagonist Pegylated Anti-CD28 Fab' Antibody Fragment in de Novo Renal Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of FR104 - Adverse Events with a focus on infectious complications. In particular
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) of FR104 as well as its potential clinical effect on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years old
- •Signed and dated written informed consent prior to any study procedure
- •First kidney transplantation
- •Willing and able to participate to the study
- •Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial (oral contraception, implant or intrauterine device) throughout the study period and for 90 days after the last dose of FR104
- •Women of childbearing potential must have a negative urinary pregnancy test the day of transplantation
- •All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of FR104, whichever is longer
- •Recipient of a kidney from deceased donor -
- •Recipient of a de novo kidney transplant able to start the immunosuppressive regimen at the protocol-specified time point
- •Recipients of a kidney with a cold ischemia time < 36 hours
- •Patients with French social security
排除标准
- •Recipient of a kidney from living donor
- •Patient at high immunological risk of rejection as determined for assessment of anti-donor reactivity:
- •High TGI >20% or Presence of pre-formed DSA with MFI>500 (results 12 weeks prior to enrollment are acceptable if no blood transfusion or abortion occurred during this period)
- •Any retransplantation and combined transplantations
- •ABO incompatible transplantation
- •HIV-positive, EBV-negative or suffering active viral hepatitis B (AgHbs positive excluded) or hepatitis C, syphilis serology- positive recipient
- •CMV negative recipients of CMV positive donors (R-D+)
- •Patient with known history of tuberculosis
- •Uncontrolled concomitant infection or any other unstable medical condition (heart failure, severe liver disease, psychiatric disorders, substance abuse) that could interfere with the study objectives
- •A known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
- •Previous history of cancer (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured)
- •Pregnant woman or likely to become pregnant or nursing
- •Patient under guardianship or trusteeship
- •Patient participating in another interventional clinical trial
- •Live viral or bacterial vaccines/treatment agents given from 3 months prior to FR104 administration (12 months for BCG vaccine)
研究组 & 干预措施
FR104 Treatment
Experimental
干预措施: FR104 (Drug)
结局指标
主要结局
Safety of FR104 - Adverse Events with a focus on infectious complications. In particular
时间窗: Until Month 12
Type, severity (grades 3 and 4 adverse effects)., number and percent of Adverse Events with a focus on infectious complications. In particular, the following cumulative incidences will be calculated: Incidence of bacterial, fungal, viral, or parasitic infection, incidence of new malignancies, lymphopenia, anemia, leucopenia, cytopenia or biochemical disturbances related to the study drug.
次要结局
- Efficacy on Renal function(Month 6 and Month 12)
- Efficacy on clinically-treated acute rejections(Month 12)
- Efficacy on multiples rejection episodes(Month 12)
- Efficacy on steroid-resistant episodes(Month 12)
- Efficacy on graft survival(Month 12)
- Treatment failure time(Month 12)
- Evaluate the appearance of Donor specific Antibodies(Month 12)
- Efficacy on Biopsy-proven acute rejection (BPAR)(Month 12)
- Efficacy on chronic allograft nephropathy(Month 12)
- Evaluate the first Biopsy-proven acute rejection time(Month 12)
研究者
研究点 (1)
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