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โ† Trials
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Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium

Recruitingn/aAges 18 Years - anyAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

Thrombotic microangiopathy (TMA) is a severe and life-threatening condition, often affecting the kidneys and brain. It can occur on the background of various clinical conditions. Dysregulation of the alternative pathway of complement may be the etiological factor and this type of TMA is classified, according to the current nomenclature, as primary atypical hemolytic uremic syndrome (HUS). Half the patients with primary atypical HUS present with rare variants in complement genes, although coexisting conditions are often needed for the TMA to become manifest. In patients with secondary atypical HUS, certain coexisting conditions appear to drive the disease and treatment should target the underlying condition to remit the TMA. Recently, the investigators demonstrated, by using a novel in-house developed functional endothelial cell-based test, that complement dysregulation and overactivatio

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 ยตL, or kidney biopsy; * Have primary atypical HUS or a coexisting condition linked to complement dysregulation: * 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. Exclusion Criteria: * Have secondary causes of hypertensive emergency, including renovascular hypertension, Cushing syndrome, aldosteronism, pheochromocytoma, thyroid disease; * 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, excluding kidney transplantation; * Received at least one of the following agents: chemotherapeutics, sirolimus, anti-VEGF agents; * Have a history of recent past exposure to illicit drug(s).
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What it tests

  • Not listed
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Where

1 site
Maastricht University Medical Center
Maastricht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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