EUCTR2010-020989-20-DE进行中（未招募）不适用
Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation - I5NP Prophylaxis of Delayed Graft Function in Kidney Transplant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part B (the subject trial portion):
- •1. Patient is at least 18 years of age.
- •2. Patient has given informed consent.
- •3. Patient is willing to practice birth control. Female / Male
- •4. Women of childbearing potential test negative for pregnancy (either urine or serum) within 48 hours prior to transplant.
- •5. Patient is up-to-date on cancer screening according to site-specific guidelines and the past medical history is negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ.
- •6. Patient is scheduled to receive kidney transplant from a deceased donor meeting the following criteria
- •Part B exclusive:
- •Receipt of an ECD kidney that has been preserved by cold storage (ECD/CS) for the entire period of cold ischemia time (CIT)*, regardless of duration
- •Receipt of an ECD kidney that has been preserved by machine perfusion (ECD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours
- •Receipt of an SCD kidney that has been preserved by cold storage (SCD/CS) where total CIT* has been at least 26 hours
- •Receipt of an SCD kidney that has been preserved by machine perfusion (SCD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours.
- •________________________
- •*CIT will be estimated at screening based on the difference between the time of aortic cross-clamping in the donor and projected initiation of the arterial anastomotic procedure in the recipient)
- •**For purposes of this study, a kidney that has been preserved by machine perfusion” means that the kidney has had any machine preservation (e.g. a kidney that was initially machine perfused but then removed from the pump and placed on cold storage, would be considered MP).
- •7. Patient is dialysis dependent at the time of transplant as documented by at least one of the following:
- •the requirement for at least 2 dialysis sessions/week during the 56 days prior to transplant, or
- •the planned removal of any remaining native kidney at the time of transplant, or
- •the investigator has provided documentation to the Medical Monitor that the patient has no remaining native renal function (e.g., documentation that the patient is anuric, with urine output <50 mL/day)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 261
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Patient has participated in an investigational drug study in the last 30 days.
- •2. Patient has known allergy or has participated in prior study with siRNA.
- •3. Patient is HCV-positive
- •4. Patient is HIV-positive
- •5. Patient is scheduled to undergo multiorgan transplantation.
- •6. Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- •7. Patient has planned transplant of kidneys from donors < 6 years of age.
- •8. Patient has planned transplant of dual kidneys (from the same donor) transplanted not en bloc (as in the case of dual ECD donor kidneys).
- •9. Patient is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another IND) for ischemic/reperfusion injury immediately prior to organ recovery.
- •10. Patient is scheduled to receive a living donor kidney.
- •11. Patient is scheduled to receive an ABO-incompatible donor kidney.
- •12. Patient is scheduled to receive an organ from a donor that meets both DCD and ECD criteria[1].
- •13. Patient is scheduled to receive an organ from a donor that meets DCD criteria (exclusion applicable to Part B only)
- •14. Patient has history or presence of a medical condition or disease that in the investigator’s assessment would place the patient at an unacceptable risk for study participation.
- •___________________________________
- •[1] ECD is defined as deceased donors 60 years of age or donors 50-59 years of age with at least two of the following: history of hypertension (HTN), death due to cerebrovascular accident (CVA) or terminal serum creatinine (SCr) >1.5 mg/dL.
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