BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs).
研究概览
简要总结
To assess the long-term safety of tegoprubart 20 mg/kg intravenous (IV) as part of a regimen along with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) in kidney transplant recipients.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A participant meeting the following criteria at the time of baseline will be considered for admission to the study: Successfully completed qualifying Parent study, where entry into the OLE was offered;
- •Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent
- •Agree not to participate in another interventional study while on treatment
- •If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6 and Table 7 (UK only)
- •If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120days after last administration of the study drug
排除标准
- •A participant who meets any of the following criteria will be excluded from this study: Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator
- •Met any of the stopping criteria or discontinued study drug in the Parent study
- •Pregnant or breastfeeding
结局指标
主要结局
Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs).
Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs).
Changes in vital signs and clinical laboratory measures.
Changes in vital signs and clinical laboratory measures.
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.
次要结局
- Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis
- The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2
- The mean eGFR at 12, 24, 36, and 48 months
- Proportion of participants with BPAR at 12, 24, 36, and 48 months
- Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
研究者
Chief Regulatory Officer
Scientific
Eledon Pharmaceuticals Inc.