An interventional study of blood draw and urine collection in Thrombotic Microangiopathies, sponsored by Sofie Dhaese. Recruiting at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Sofie Dhaese · Not applicable, Interventional, and Treatment
Study rationale: Viral infections, such as CMV, are a risk factor for TA-TMA (transplantation-associated TMA). Viral infections increase interferon (IFN) levels and high IFN levels are associated with thrombotic microangiopathy (TMA). IFNs contribute to TMA pathogenesis through suppression of VEGF transcription. Disruption of the VEGF signalling pathway in the kidney is associated with TMA.
Primary objective: To determine the association between IFN levels and the development of biopsy-proven or clinically diagnosed TA-TMA.
Secondary objective(s): To explore the relationship between complement activation and IFN in patients with TMA.
To explore if high IFN levels are associated with low VEGF-A levels. Endpoint: The study aims to investigate the role of IFN in the pathogenesis of secondary thrombotic microangiopathy (focusing on patients with TA-TMA). It seeks to clarify whether IFN, next to complement dysregulation, is a driver of endothelial damage and TMA in these patients.
52 studies on the registry are indexed under Thrombotic Microangiopathies; 21 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 24 interventional studies indexed under Thrombotic Microangiopathies.
Browse Thrombotic Microangiopathies studies →This is the only study on the registry with Sofie Dhaese as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants eligible for inclusion in this study must meet all of the following criteria:
Specifically for the patients with TMA (G1 and G4):
Clinical diagnosis of TMA based on the following criteria, with ≥4 out of 6 features fulfilled within 14 days (15,52,53):
de novo Coombs negative hemolytic anemia OR (in case of HSCT)
otherwise unexplained de novo thrombocytopenia (\< 50 x 109/L) OR a 25% decrease in count OR (in case of HSCT)
Specifically for the group of patients without TMA, with infection (G2):
Specifically for the group of patients without TMA, without infection (G3):
Exclusion Criteria:
Participants eligible for this study must not meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
blood and urine collection
Other: blood draw · Other: urine collection
blood and urine collection
Other: blood draw · Other: urine collection
blood and urine collection
Other: blood draw · Other: urine collection
blood and urine collection
Other: blood draw · Other: urine collection
blood sampling at designated time points
urine collection at designated time points
Interferon signature
6-gene interferon signature
Time frame: Time point 1: baseline Time point 2: up to week 52
VEGF-A
VEGF-A level
Time frame: Time point 1: baseline Time point 2: up to week 52
Complement analysis (serum)
CH50, AP50, C3, C3d, C4 and C5b-9 at timepoint 1 and C5b-9 at time point 2
Time frame: Time point 1: baseline Time point 2: up to week 52
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Thrombotic Microangiopathies →