EUCTR2010-019243-19-GB进行中（未招募）1 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 Version 8.0
试验速览
- 阶段
- 1 期
- 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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
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
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
进行中（未招募）
不适用
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 DeathPatients suffering from end-stage renal disease, receiving a donor kidney from donors after cardiac deathMedDRA version: 17.0Level: LLTClassification code 10014647Term: End stage renal failureSystem Organ Class: 100000004857EUCTR2010-019243-19-ESAngion Biomedica Corp.36
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