Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT04745195
Eligibility Criteria:
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 µL, 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04745195
Study Brief:
Protocol Section:
NCT04745195