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Can Real-World data unlock clues to a deadly Post-Transplant complication?

NCT ID NCT07732361

Knowledge-focused Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study looks back at medical records of children and adults who developed a serious blood-clotting condition called thrombotic microangiopathy (TMA) within a year after a stem cell transplant. Researchers aim to understand survival rates and causes of death in these patients, whether or not they received a specific treatment. The goal is to gather real-world evidence that could guide future care.

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

307 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study included pediatric and adult participants who were diagnosed with TMA within 52 weeks after an HSCT procedure and who were either complement inhibitor treatment naïve or had been treated with eculizumab. Data was collected from medical records in 41 study centers across 10 countries

Ages

4 weeks 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: * Participant must be ≥ 28 days of age at the time of TMA diagnosis. * Body weight ≥ 5 kg at the time of TMA diagnosis. * Documented TMA on/after 01 Jan 2010 to 30 Jun 2024 with concurrent renal dysfunction with no documented alternative explanation ≤ 52 weeks from the HSCT. * Documentation of participant's vital status through 52 weeks after the date of TMA diagnosis. * Documentation of date and type of HSCT, date of TMA, absence of acute GVHD, and infection status at time of TMA diagnosis. * Documentation of at least 2 of the following: indication for most recent HSCT, serum creatinine at time of TMA diagnosis, presence of multiorgan dysfunction at time of TMA diagnosis. * Informed consent obtained if required by local regulations. Exclusion Criteria: * Medical Conditions (Ongoing at the Time of TMA Diagnosis): TTP, ST-HUS, Immune-mediated hemolysis not due to TMA, DIC, Bone marrow/graft failure of HSCT, VOD (regardless of severity), HIV infection, Sepsis that required vasopressor support. * Prior/Concomitant Therapy: Received a complement inhibitor other than eculizumab from time of suspicion of HSCT-TMA diagnosis through 52 weeks post-HSCT-TMA diagnosis.. * Other Exclusions: Participation in an investigational drug or device study for the treatment of TMA within 30 days prior to TMA diagnosis or during the 52 weeks following TMA diagnosis.

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Conditions

The condition(s) this trial relates to.

thrombotic microangiopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic stem cell transplant Thrombotic microangiopathy

Contacts and locations

Locations

  • Research Facility

    Boston, Massachusetts, 02215, United States

  • Research Facility

    Akron, Ohio, 44308, United States

  • Research Facility

    Salt Lake City, Utah, 84108, United States

  • Research Facility

    Brussels, Brussels Capital, 1020, Belgium

  • Research Facility

    Liège, 1020, Belgium

  • Research Facility

    Fortaleza, Ceará, 60430-372, Brazil

  • Research Facility

    Brasília, Federal District, 70684-831, Brazil

  • Research Facility

    Curitiba, Paraná, 80060-900, Brazil

  • Research Facility

    Recife, Pernambuco, 52010-010, Brazil

  • Research Facility

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Research Facility

    Jaú, São Paulo, 17210-120, Brazil

  • Research Facility

    Rio de Janeiro, 20230-130, Brazil

  • Research Facility

    São Paulo, 04023-064, Brazil

  • Research Facility

    São Paulo, 05403-000, Brazil

  • Research Facility

    São Paulo, 05410-030, Brazil

  • Research Facility

    São Paulo, 15090-000, Brazil

  • Research Facility

    Pessac, Gironde, 33604, France

  • Research Facility

    Toulouse, Haute Garonne, 31059, France

  • Research Facility

    Grenoble, Isere, 38043, France

  • Research Facility

    Paris, 75475, France

  • Research Facility

    Thessaloniki, Central Macedonia, 57010, Greece

  • Research Facility

    Pátrai, West Greece, 26500, Greece

  • Research Facility

    Rome, Lazio, 00168, Italy

  • Research Facility

    Ancona, 60126, Italy

  • Research Facility

    Brescia, 25123, Italy

  • Research Facility

    Florence, 50134, Italy

  • Research Facility

    Genova, 16147, Italy

  • Research Facility

    Naples, 80123, Italy

  • Research Facility

    Pavia, 27100, Italy

  • Research Facility

    Roma, 00165, Italy

  • Research Facility

    Torino, 10126, Italy

  • Research Facility

    Fukushima, Fukushima, 960-1295, Japan

  • Research Facility

    Tsukuba, Ibaraki, 305-8576, Japan

  • Research Facility

    Saitama-shi, Saitama, 330-8777, Japan

  • Research Facility

    Wakayama, Wakayama, 641-8510, Japan

  • Research Facility

    Seoul, 03080, South Korea

  • Research Facility

    Seoul, 05505, South Korea

  • Research Facility

    Seoul, 06351, South Korea

  • Research Facility

    Barcelona, 08041, Spain

  • Research Facility

    Barcelona, 08950, Spain

  • Research Facility

    London, Greater London, W12 0HS, United Kingdom

  • Research Facility

    Newcastle, Tyne & Wear, NE1 4LP, United Kingdom

  • Research Facility

    Birmingham, West Midlands, B4 6NH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.