(TNX-1500) in Kidney Transplant Recipients

Официальное название

Phase II Clinical Trial Evaluating the Safety and Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients

Обзор

The primary objective is to investigate the safety and efficacy of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.

Вмешательства

• Препарат TNX-1500
  This is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.
• Процедура Kidney Transplant
  Kidney Transplant

Первичные конечные точки

• Number of Adverse Events in each subject [Срок оценки: 12 Months]
• Number of Serious Adverse Events in each subject [Срок оценки: 12 Months]

Вторичные конечные точки (9)

• Incidence of Biopsy Proven Acute Rejection [Срок оценки: 12 months]
• Incidence of treatment for acute rejection [Срок оценки: 12 Months]
• Incidence of de novo DSA development [Срок оценки: Months 1, 3, 6, 9, 12]
• Incidence of serious opportunistic infections and malignancies [Срок оценки: 12 months]
• GFR measurement [Срок оценки: 12 months]
• Incidence of death [Срок оценки: 12 months]
• Incidence of graft loss [Срок оценки: 12 months]
• Degree of Proteinuria [Срок оценки: 12 Months]
• Degree of albuminuria [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• Male or female subjects ≥18 to 75 years of age.
• Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.
• Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant)
• Ability to understand the study requirements and provide written informed consent.
• Epstein-Barr virus (EBV) seropositive

Критерии исключения

• Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.
• Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.
• Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.
• Left ventricular ejection fraction < 40% as determined by TTE or clinical evidence of heart failure.
• Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
• Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:

• Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.
• Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.
• Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (<1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.
• Total abstinence
• Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.
• Subjects with clinically significant lab abnormalities (>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:

• Alanine aminotransferase (ALT)
• Aspartate aminotransferase (AST)
• Alkaline phosphatase (ALP)
• Bilirubin
• Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))
• Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.
• Subject receives an organ at high risk for delayed graft function, including from a deceased donor after cardiac death (DCD) or a high Kidney Donor Profile Index ≥85%.
• Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) >20% based upon results within 6 months prior to transplant.
• Virtual crossmatch (VXM) positive transplant with an MFI >1000 as assessed by routine methodology (Luminex)
• Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative
• Multi-organ transplant or tissue recipient.
• History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix
• Subjects with any of the following: hemoglobin <8 mg/dL, white blood cell ≤2,000/mm3, or platelet count ≤75,000/mm3.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Massachusetts General Hospital — Boston
• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07204080 · 2025P-------

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗