AT-1501-K209: 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
- Enrolling By Invitation
- 入组人数
- 132
- 试验地点
- 43
- 主要终点
- Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
研究概览
简要总结
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
详细描述
This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.
The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.
Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table
- •If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.
排除标准
- •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.
研究组 & 干预措施
AT-1501
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
干预措施: AT-1501 (Drug)
Tacrolimus
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
时间窗: Assessed from date of enrollment through Month 48
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Safety and Tolerability - Kidney Transplant Medication Side Effects
时间窗: Assessed from date of enrollment through Month 48
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
次要结局
- Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months(Assessed from date of enrollment through Month 48)
- The proportion of patient and graft survival at 12, 24, 36, and 48 months(Assessed from date of enrollment through Month 48)
- The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months(Assessed from date of enrollment through Month 48)
- Proportion of participants with BPAR at 12, 24, 36, and 48 months(Assessed from date of enrollment through Month 48)