EUCTR2015-003078-33-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant - QPI-1002 Phase 3 DGF
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 634
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
- •1. Has the ability to understand the requirements of the study, is able to provide written informed consent (including consent for the use and disclosure of research related health information) and is willing and able to comply with the requirements of the study protocol (including required study visits).
- •2. Male or female at least 18 years of age.
- •3. Has dialysis dependent renal failure initiated at least 2 months prior to transplantation.
- •4. Is to be a recipient of a transplant from a deceased donor (brain death criteria) ? 45 years of age.
- •5. Based on donor age, the following requirements for the risk of DGF (determined using the Irish DGF risk assessment nomogram) and cold ischemia time (CIT) must be met:
- •a. Donor age 45 ? 59 years: estimated DGF risk >= 20% and estimated CIT >= 16 hour
- •b. Donor age >= 60 years: no minimum estimated DGF risk or minimum estimated CIT
- •6. Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.
- •7. A female subject is eligible to enter the study if she is:
- •a. Not pregnant or nursing
- •b. Of non-childbearing potential (i.e., post-menopausal defined as having been amenorrheic for at least 1 year prior to screening, or has had a bilateral tubal ligation at least 6 months prior to administration of study drug or bilateral oophorectomy or complete hysterectomy).
- •c. If of childbearing potential, must have a negative serum pregnancy test within 48 hours prior to transplant surgery and be using an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Day 180 visit.
- •8. Male subjects with female partners of childbearing potential must agree to use an effective means of contraception (per the site-specific guidelines or use 2 methods of birth control concurrently, whichever is more stringent), which will be continued until the Day 180 visit.
- •9. Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
- •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 507
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
排除标准
- •1. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
- •2. Recipient of donor kidney preserved with normothermic machine perfusion.
- •3. Scheduled to undergo multiorgan transplantation.
- •4. Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- •5. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- •6. Has lost first kidney transplant due to graft thrombosis.
- •7. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
- •1. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
- •2. Recipient of donor kidney preserved with normothermic machine perfusion.
- •3. Scheduled to undergo multiorgan transplantation.
- •4. Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- •5. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- •6. Has lost first kidney transplant due to graft thrombosis.
- •7. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
- •8. Is scheduled to receive an ABO-incompatible donor kidney.
- •9. Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC cross-match method, if performed.
- •10. Has a positive T- or B-cell flow cross-match AND donor specific anti-HLA antibody (DSA) detected by flow cytometry, Luminex® based antigen-specific anti-HLA antibody testing, or by similar methodology, if performed.
- •11. Has undergone desensitization to remove donor specific anti-HLA antibodies prior to transplantation.
- •12. Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest.
- •13. Has known allergy to or has participated in a prior study with siRNA.
- •14. Has a history of HBV (Note: subjects with a serological profile suggestive of clearance, or prior antiviral treatment of a prior HBV infection, may be enrolled with the approval of the Medical Monitor).
- •15. Has a history of HIV.
- •16. Recipient of a known HIV positive donor kidney.
- •17. Is HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an approved antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled. Subjects who have been cleared of HCV virus after treatment with an unapproved regimen should be approved by the Medical Monitor).
- •18. Has history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would place the patient at an unacceptable risk for study participation.
研究者
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