The COMplement Prospective Evaluation of Thrombotic microangiopathy on Endothelium (COMPETE) Study - COMPETE

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 42 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all
•of the following criteria:
•- Males or females at least 18 years of age;
•- Have acute kidney injury, defined as estimated GFR <45 mL/min/1.73m2;
•- Have documented TMA either on peripheral blood, defined as Coombs negative
•microangiopathic hemolytic anemia (hematocrit <30%, hemoglobin <6.5 mmol/L [<10
•g/dL], lactate dehydrogenase >500 U/L, and either schistocytes on peripheral
•blood smear or undetectable haptoglobin), and platelets <150,000 per µL, or
•kidney biopsy;
•- Have primary atypical HUS or a coexisting condition linked to C-TMA:
•-- Hypertensive emergency, defined as SBP/DBP of >180/120 mmHg and impending
•organ damage secondary to hypertension (at least one of the following:
•neurologic disease, hypertensive retinopathy grade III and/or IV, left
•ventricular hypertrophy); OR
•-- Pregnancy, including 12 weeks postpartum; OR
•-- Kidney donor recipient; OR
•-- Systemic auto-immune disease associated with TMA, including systemic
•sclerosis, systemic lupus erythematosus, anti-phospholipid syndrome;
•- Have the ability to understand the requirements of the study, provide written
•informed consent, and comply with the study protocol procedures.

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•- Have secondary causes of hypertensive emergency, including renovascular
•hypertension, Cushing syndrome, aldosteronism, pheochromocytoma, thyroid
•- Have a nephropathy not related to thrombosis on kidney biopsy;
•- Have ADAMTS13 deficiency, defined as ADAMTS13 activity <10%;
•- Have a positive stool culture for Shiga toxin producing bacteria;
•- Have positive serologic test for viral infections, including HIV and CMV;
•- Have a history of malignant disease, excluding non-melanoma skin cancer;
•- Have a history of bone marrow or solid organ transplantation;
•- Received at least one of the following agents: chemotherapeutics, calcineurin
•inhibitors, sirolimus, anti-VEGF agents;
•- Have a history of recent past exposure to illicit drug(s).

发起方

Medisch Universitair Ziekenhuis Maastricht