2023-503336-41-00招募中2 期
BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 14
- 主要终点
- The mean estimated glomerular filtration rate (eGFR) at 12 months.
研究概览
简要总结
To assess the graft function at 12 months post-transplant in tegoprubart treated participants compared to tacrolimus treated participants.
研究设计
- 分配方式
- Randomized
- 主要目的
- Post-transplant Treatment (Day 1 through Month 12, or Month 13)
- 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
- 是
入选标准
- •Participants meeting all of the following criteria at the time of Screening will be considered for admission to the study: 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;
- •Male or female ≥ 18 years of age;
- •Recipient of their first kidney transplant from a living or deceased donor;
- •Willing and able to comply with the study requirements including prohibited concomitant medication restrictions;
- •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 serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from Screening, through 120 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 120 days after last administration of the study drug and agree to not donate sperm for 120 days after last administration of the study drug;
排除标准
- •A patient who meets any of the following criteria will be excluded from this study: Induction therapy, other than study-assigned rATG, planned as part of initial immunosuppressive regimen;
- •Known hypersensitivity to tegoprubart, tacrolimus, mycophenolate, rATG, corticosteroids, or any of their components;
- •Active substance abuse within 1 year prior to Screening;
- •Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies;
- •Clinically significant abnormal ECG at Screening;
- •Recipient is seronegative for EBV at Screening;
- •Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening;
- •Thrombocytopenia (platelets < 75,000 per mm 3), leukopenia (white blood cells [WBC] < 3,000 per mm 3), or anemia (hemoglobin < 8 g/dL) at Screening;
- •Desensitization therapy within 6 months of transplant;
- •Pregnancy or breastfeeding;
- •Unlikely to comply with the visits scheduled in the protocol, in the opinion of the Investigator;
- •History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation or long-term antiplatelet medication
- •Active coronavirus disease 2019 (COVID-19) infection at time of Screening or a recent history of COVID infection within 30 days prior to enrollment.
- •Currently treated with corticosteroids other than topical or inhaled corticosteroids;
- •Previous treatment with tegoprubart or any other anti-CD40L treatment.
- •Previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi-organ or dual-kidney transplant;
- •Will receive a kidney with an anticipated cold ischemia time of > 30 hours;
- •Will receive a kidney from a donor that meets any of the following: Donation after Cardiac Death (DCD) criteria; Or Kidney Donor Profile Index (KDPI) of > 85%; Or Is blood group (ABO) incompatible;
- •History of any other acute or chronic medical condition, psychiatric disorder or pre-planned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results;
- •Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants;
- •Recipient of an organ from an HLA identical living related donor.
- •Recipient or donor is seropositive for human immunodeficiency virus (HIV), hepatitis B (HBV) surface antigen, or HBV core antibody or Hepatitis C (HCV). For HCV, a positive HCV antibody test is exclusionary unless the recipient is known to have been treated for HCV, in which case HCV RNA can be measured, and the recipient would only be excluded if HCV RNA positive;
- •Current calculated panel reactive antibody (cPRA) > 80%;
- •Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully;
- •Elevate daspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 3 times the upper value of the normal range at screening and impaired liver function;
- •Current or history of active tuberculosis infection. Laboratory evidence of infection (positive PPD or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed treatment as recommended by local authorities; a. Participants with documented Bacillus CalmetteGuerin (BCG) vaccination and a negative chest x-ray may be included at the Investigator’s discretion;
- •Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 half-lives (depending on medication and whatever is longer) prior to Screening;
- •Treatment with an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin) within 90 days of Screening;
结局指标
主要结局
The mean estimated glomerular filtration rate (eGFR) at 12 months.
The mean estimated glomerular filtration rate (eGFR) at 12 months.
次要结局
- The rate of graft functional impairment at 12 months. A participant is considered to have graft functional impairment if they either: A) Have an eGFR <60 mL/min/1.73m2 or B) Have a decrease in eGFR ≥ 10 mL/min/1.73m2 from Month 1 to Month 12;
- The rate of NODAT at 12 months post-transplant;
- The rate of patient and graft survival at 12 months post-transplant. Patient and graft survival are defined as either A) Death, B) Re-transplantation or C) Requirement for regular dialysis;
- Rate of BPAR-free patient and graft survival at 12 months post-transplant;
- Rate of BPAR at 12 months.
研究者
Chief Regulatory Officer
Scientific
Eledon Pharmaceuticals Inc.
研究点 (14)
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