NCT05907096进行中（未招募）2 期
A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- argenx
- 入组人数
- 103
- 试验地点
- 45
- 主要终点
- eGFR at 24 weeks posttransplant
研究概览
简要总结
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks.
The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
- •Agree to use contraceptive measures consistent with local regulations
- •Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
- •Are recipients of de novo or second-time, single kidney transplant from a deceased donor, either DCD (donation after cardiac/circulatory death) or DBD ( (donation after brain death)
- •Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys
- •Have a negative cross match
- •Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant
排除标准
- •Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- •Any known history of complement deficiency
- •Evidence of peritonitis in participants on peritoneal dialysis
- •Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
- •High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
- •Clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- •Clinically significant active bacterial, viral, or fungal infection
- •History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- •History of current alcohol, drug, or medication abuse as assessed by the investigator
- •Pregnant or lactating state or intention to become pregnant during the study
- •The full list of criteria can be found in the protocol.
研究组 & 干预措施
ARGX-117
Experimental
Patients receiving ARGX-117 intravenous infusions
干预措施: ARGX-117 (Biological)
Placebo
Placebo Comparator
Patients receiving placebo intravenous infusions
干预措施: Placebo (Other)
结局指标
主要结局
eGFR at 24 weeks posttransplant
时间窗: Up to 24 weeks
Estimated glomerular filtration rate
次要结局
- Proportion of participants with Delayed Graft Function (DGF)(Up to 52 weeks)
- Proportion of participants with fDGF(Up to 52 weeks)
- Duration of dialysis treatment for DGF within the first 30 days posttransplant(up to 30 days)
- Proportion of participants who have ongoing dialysis requirement at study day 31(Up to 31 days)
- CRR at 72 hours posttransplant and on study day 8(up to 8 days)
- iBox score at 52 weeks posttransplant(up to 52 weeks)
- Dialysis-free participant survival through 52 weeks posttransplant(up to 52 weeks)
- (Death-censored) allograft survival through 52 weeks posttransplant(Up to 52 weeks)
- eGFR at 52 weeks posttransplant(up to 52 weeks)
- Incidence of PNF(up to 12 weeks)
- Serum concentrations for ARGX 117(up to 64 weeks)
- Changes from baseline in free C2, total C2, and CH50(up to 64 weeks)
- Incidence of anti-drug antibodies (ADA) against ARGX-117(up to 64 weeks)
研究者
研究点 (45)
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