Examining complement-related thrombotic microangiopathy that injures the blood vessel lining

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling adults with acute kidney injury and documented thrombotic microangiopathy. Participants will undergo a novel, in-house endothelial cell-based functional test alongside standard clinical and laboratory data collection to identify complement pathway overactivation. The study includes patients with primary atypical HUS and those with secondary TMA linked to triggers such as hypertensive emergency, pregnancy (including up to 12 weeks postpartum), recent kidney donation/recipient status, or systemic autoimmune disease. All testing and data collection are performed at Maastricht University Medical Center to correlate test results with clinical presentation and outcomes.

Why it matters

Who can join: the full rules

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).

Where it's running

• Maastricht University Medical Center
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Pieter van Paassen, MD, PhD — Maastricht University Medical Center
• Study coordinator: Sjoerd A.M.E.G. Timmermans, MD, PhD
• Email: sjoerd.timmermans@mumc.nl
• Phone: +31(0)433871198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.