Status:
RECRUITING
Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Thrombotic Microangiopathies
Hemolytic Uremic Syndrome, Atypical
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04745195
Start Date
August 11 2021
End Date
December 31 2026
Last Update
October 1 2025
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX