Blood test could unlock precision medicine for deadly TMA
NCT ID NCT04745195
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new blood test (the HMEC test) to see if it can better identify which patients with thrombotic microangiopathy (TMA) have a specific immune system problem driving their disease. TMA is a severe condition that damages kidneys and the brain. The researchers hope this test will help doctors choose the right treatment for each patient. The study will enroll 42 adults with acute kidney injury and TMA.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HMEC test (a blood test that measures complement activity on endothelial cells)
- What this could lead to
- If successful, this test could help doctors identify which TMA patients have complement-driven disease, leading to more targeted treatments and better outcomes.
- What could go wrong
- This is a small, early-stage study (42 participants) focused on diagnosis, not treatment. The test may not prove accurate enough for routine use, and results may not apply to all TMA patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients of at least 18 years of age presenting with TMA, either on peripheral blood or kidney biopsy, will be recruited at the emergency departments of (regional) hospitals affiliated to the Limburg Renal Registry, Maastricht University Medical Center, Maastricht, NLD. Patients who meet the eligibility criteria will be included.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Maastricht University Medical Center
RECRUITINGMaastricht, Limburg, 6229HX, Netherlands
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