EUCTR2010-019243-19-ES进行中（未招募）不适用
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 Version 8.0
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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.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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
相似试验
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 DeathDelayed graft function1002914910038365NL-OMON39114Angion Biomedica Corp.18
进行中（未招募）
1 期
Exploratory Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac DeathEUCTR2010-019243-19-GBAngion Biomedica Corp.36
撤回
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.NL-OMON32550Angion Biomedica Corp.30
尚未招募
不适用
BB3 in Kidney Transplantation.End-stage renal diseasekidney transplantationnierfalenniertransplantatieNL-OMON22050Angion Biomedica Europe LimitedAngion Biomedica Corp.1050 Stewart AvenueGarden City, NY 1153036
Unknown
2 期
Study on Delayed Graft Function Using Paired KidneysDelayed Graft FunctionNCT01561599Angion Biomedica Corp12