A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- argenx
- 入组人数
- 33
- 试验地点
- 37
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is within the ages of 18 and 80 years old
- •The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
- •The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
- •A participant may be allowed into the study if they receive the following medications:
- •Received mycophenolate mofetil for at least 20 weeks before the study
- •Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
- •Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
- •Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
排除标准
- •Confirmed T-cell or mixed rejection at time of the study
- •Recent change in immunosuppressive therapy agents
- •Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
- •Pregnant or lactating state or intention to become pregnant during the study
- •The complete list of criteria can be found in the protocol
研究组 & 干预措施
Treatment arm 1
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
干预措施: Efgartigimod PH20 SC - prefilled syringe (Combination Product)
Treatment arm 2
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48
干预措施: Efgartigimod PH20 SC - prefilled syringe (Combination Product)
Treatment arm 2
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48
干预措施: Placebo PH20 SC - prefilled syringe (Other)
Treatment arm 3
Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
干预措施: Placebo PH20 SC - prefilled syringe (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 78 weeks
Percentage of participants with permanent treatment discontinuation due to adverse events (AEs)
时间窗: Up to 48 weeks
次要结局
- Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR)(Up to 72 weeks)
- Urine protein creatinine ratio (UPCR)(Up to 72 weeks)
- Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time(Up to 72 weeks)
- Histological changes in kidney biopsy(Up to 72 weeks)
- Incidence of antibodies against rHuPH20 in plasma over time(Up to 72 weeks)
- Graft and participant survival(Up to 72 weeks)
- Percentage change from baseline in total IgG levels in serum over time(Up to 60 weeks)
- Efgartigimod serum concentration-time profile and PK parameter Ctrough(Up to 48 weeks)
- Proportion of participants with biopsy-proven histologic resolution (BPHR) over time(Up to 72 weeks)
- Changes from baseline in AMR/MVI index score over time(Up to 72 weeks)