NL-OMON39114已完成2 期
Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death - BB3 in kidney transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
- •2. Males and females * 18 years of age.
- •3. Had renal transplantation due to end stage disease requiring chronic dialysis.
- •4. Study drug can be administered within 6 to 36 hours after transplantation.
- •5. Received kidney from donor after cardiac death.
- •6. DCD kidney fulfills the clinical site*s criteria for transplantation.
- •7. Creatinine clearance from the transplanted kidney over a 2-hour collection period is <10 mL/min, OR no urine output or < 50 cc/H over a 24 hour period, OR normal urine output following transplantation that diminished to < 50 cc/H over a 24 hour period OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is < 30%.;8. Dry weight * 100 kg.
- •9. Women of child bearing potential have a negative pregnancy test prior to transplantation.
- •10. Women of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year) must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the 28-day study period. Men must agree to use condoms during the study period; a condom with spermicide is considered a single barrier.
- •11. In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
排除标准
- •1. Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2.
- •2. Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
- •3. Recipient of kidney from a pediatric donor age 10 years or less.
- •4. Recipient age > 75 years.
- •5. Patients with ASA 4 or 5
- •6. Patients with chronic obstructive pulmonary disease (COPD) GOLD IV
- •7. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
- •8. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrolment into this study.
- •9. Concurrent sepsis or active bacterial infection.
- •10. Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- •11. Women of child bearing potential who is breast feeding.
- •12. History of positive HIV test.
- •13. History of rheumatoid arthritis.
- •14. History of proliferative retinopathy or laser surgery for retinopathy.
- •15. Subjects who have a penicillin allergy.
- •16. Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, or are receiving ciprofloxacin and fluvoxamine (Luvox®).;17. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
- •18. Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject*s primary nephrologist.
研究者
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