NCT07696962尚未招募1 期
Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Xeno Holdings (US), LLC dba ChoironeX2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
研究概览
简要总结
The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months
- •Eligible for kidney transplantation per site criteria
- •<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
- •Blood type and immunologic compatibility with study transplant confirmed by testing
- •EBV seropositive
- •Up to date on recommended vaccinations for immunocompromised individuals
- •Willing to use protocol-required contraception
- •Able to provide informed consent and comply with lifelong follow-up
排除标准
- •Requirement for multi-organ transplantation
- •Living donor available who is ABO-incompatible
- •Kidney disease with high risk of post-transplant recurrence
- •Polycystic kidney disease without prior native nephrectomy
- •Unable or unwilling to comply with study procedures
- •History of non-adherence to medical treatment
- •Identified as vulnerable by psychological assessment
- •Significant uncontrolled psychiatric illness
- •Inadequate social support or caregiver unavailable/unwilling
- •Current drug or alcohol misuse
- •Serious non-renal illness with life expectancy <1 year
- •BMI <16 or >35 kg/m²
- •Known hypercoagulable disorder
- •Uncontrolled hypertension or hemodynamic instability at enrollment
- •Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment
- •Serious liver disease or impaired liver function
- •Diabetes mellitus with poor glycemic control (HbA1c >10%)
- •Active infection at time of transplantation
- •Positive serology for hepatitis B, hepatitis C, or HIV
- •Current, active, or untreated tuberculosis
- •Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer
- •Current systemic immunosuppressive therapy (excluding permitted corticosteroids)
- •Participation in another interventional drug trial within 60 days prior to enrollment
- •Pregnant or breastfeeding
- •Known severe hypersensitivity to a required study medication with no acceptable alternative
研究组 & 干预措施
Porcine Thymokidney
Experimental
Porcine Thymokidney transplanted into patients with End Stage Renal Disease
干预措施: ChoironeX GalKO Porcine Thymokidney (Biological)
结局指标
主要结局
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
时间窗: 6 months
Overall survival of the recipient without the need for chronic dialysis at Month 6.
时间窗: 6 months
次要结局
- Overall survival without the need for dialysis at Month 3.(3 months)
- Graft survival free from hyperacute rejection at Day 3.(3 Days)
- Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6.(6 months)
- Banff classification of xenograft pathology at biopsy.(6 months)
- Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6.(6 months)
- Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6.(6 months)
- Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6(6 months)
- Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6.(6 months)
- Change from baseline in blood pressure at Months 3 and 6.(6 months)
- Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts.(6 months)
- Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects.(6 months)
- Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6.(6 months)
- New-onset diabetes after transplant (NODAT) through Month 6.(6 months)
- Change from baseline in BMI at Months 3 and 6.(6 months)
- Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the EuroQol 5-Dimension 5-Level Questionnaire.(6 months)
- Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Standardized Outcomes in Nephrology Life Subject Questionnaire.(6 months)
- Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire.(6 months)
- Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Patient Global Impression of Change Questionnaire.(6 months)
- Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA).(6 months)
- Duration of initial hospitalization.(6 months)
- Duration of ICU care during initial hospitalization.(6 months)
- Number of hospitalizations through Month 6.(6 months)
- Time to thymokidney explant, and time to restarting dialysis after explant (if relevant).(6 months)
- Incidence of temporary dialysis treatments through Month 6.(6 months)
- Number of dialysis-free days through Month 6.(6 months)
- Time from transplant to first dialysis treatment (if relevant).(6 months)
研究者
研究点 (2)
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