ISRCTN42763074进行中（未招募）2 期
A Phase 2 randomized, prospective, partially double-blind, placebo-controlled trial to evaluate the preliminary efficacy and safety of inhaled carbon monoxide upon kidney function in kidney transplant recipients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female adult subjects (age 18-75) undergoing deceased kidney-only transplants, including machine-perfused kidneys.
- •2. Recipients of both donation after brainstem death (DBD) and donation after circulatory death (DCD) kidney transplants will be included.
- •3. Clinically stable in the opinion of the Investigator.
- •4. Willing and able to comply with the requirements of the study protocol (including required study visits).
- •5. Able to provide written informed consent (including consent for the use and disclosure of research-related health information).
- •6. A female subject is eligible to enter the study if she is:
- •6.1. Not pregnant or nursing
- •6.2. Female subjects of childbearing potential must have a negative serum pregnancy within 48 hours prior to transplant surgery and must use a highly acceptable method of contraception for at least 3 months prior to the first administration of trial drug and for 28 days after the last administration of trial drug, as defined in the protocol.
- •6.3. In order to be considered not of childbearing potential,” female subjects must be postmenopausal for at least 1 year at Screening and 1 year of amenorrhea, or have been irreversibly surgically sterilized by complete hysterectomy, oophorectomy, or bilateral tubal ligation for at least 6 months prior to the first administration of the trial drug.
- •7. Male subjects whose female partners are of childbearing potential (defined as above) must agree to use an acceptable method of birth control for the duration of trial treatment and for 28 days after the last administration of trial drug.
排除标准
- •1. Age less than 18 years or greater than 75.
- •2. Patients who lack mental capacity to give informed consent.
- •3. Multi-organ transplant recipients.
- •4. Subjects who are currently or, in the past 60 days, have been on experimental or unapproved medications, or who have been actively enrolled in a clinical trial investigating new therapies. Subjects enrolled in other observational (non-interventional) studies will not be excluded.
- •5. Subjects with significant pre-transplant anemia, whose serum Hb is < 7.8 g/dl at screening. Subjects who drop below a Hb of 7.8 g/dL would receive a blood transfusion to maintain Hb >7.7 g/dL and therefore remain in the trial.
- •6. Subjects who are Jehovah’s witnesses or other subjects who will not accept blood transfusions.
- •7. Subjects who, in the opinion of the investigator, have unstable medical issues rendering them at significantly greater risk for adverse events in the peri-operative period, and specifically patients with a recent new-onset (<6 months from screening) history of one or more of the following:
- •7.1. myocardial infarction (MI)
- •7.2. transient ischemic accident (TIA)
- •7.3. cerebrovascular accident (CVA)
- •7.4. clinically significant abnormal ECG changes
- •8. New focal neurological signs at screening or Day 0 (Visit 1).
- •9. Abnormal neuro-psychological test at screening.
- •10. Patients with significant pulmonary gas exchange compromise or conditions, such as interstitial lung disease or severe emphysema, and all subjects who have baseline oxygen saturations on room air of <90%.
- •11. Subjects with baseline carboxyhemoglobin [COHb] levels = 2%.
- •12. Subjects who do not have a central venous catheter placed pre- or intra-operatively that may be used for venous blood sampling.
- •13. BMI > 40 kg/m2
- •14. Subjects who are being transplanted pre-emptively (not yet on dialysis)
- •15. Are pregnant, plan to become pregnant during this trial, are nursing mothers or are unwilling to use an acceptable method of contraception for the duration of the trial.
- •16. Have any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subjects’ treatment, assessment, or compliance with the protocol.
- •17. Have a history or suspicion of unreliability, poor cooperation, or non-compliance with medical treatment.
- •18. Have previously been randomized in this trial.
- •19. Have any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the trial.
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