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Blood test could unlock precision medicine for deadly TMA

NCT ID NCT04745195

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, Limburg, 6229HX, Netherlands

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