AzTrials
AzTrials

Thrombotic MicroangiopathiesROSARIONCT07705789

The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy

A study testing blood draw and urine collection in people with Thrombotic Microangiopathies, run by Sofie Dhaese at 3 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombotic Microangiopathies
What is being tested?
blood draw and urine collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesBelgium
Study dates
15 Sep 2026to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants eligible for inclusion in this study must meet all of the following criteria:
  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  • Specifically for the patients with TMA (G1 and G4):
  • Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation OR patients with DITMA AND
  • Tissue diagnosis of TMA (pathological diagnosis) OR
Show all 25Show fewer
  • 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)
  • failure to achieve transfusion independence despite neutrophil engraftment
  • hemoglobin decline by ≥ 1g/dL
  • new onset transfusion dependence
  • otherwise unexplained de novo thrombocytopenia (< 50 x 109/L) OR a 25% decrease in platelet count OR (in case of HSCT)
  • failure to achieve platelet engraftment despite neutrophil engraftment
  • higher than expected transfusion needs
  • refractory to platelet transfusion *≥50% reduction in platelet count after full platelet engraftment
  • lactate dehydrogenase (LDH) above the upper limit of normal
  • schistocytes (=>2 / high power field (HPF)
  • new onset hypertension OR worsening of existing hypertension requiring additional antihypertensive therapy
  • proteinuria > 1g/g creatinine on a random urine protein-to-creatinine ratio Date of TMA diagnosis = first date when ≥4 out of the 6 features are fulfilled.
  • Specifically for the group of patients without TMA, with infection (G2):
  • Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
  • Symptomatic viral infection (evaluated by the treating physician).
  • Specifically for the group of patients without TMA, without infection (G3):
  • Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
  • No symptomatic viral infection (evaluated by the treating physician).

Who cannot join

  • Participants eligible for this study must not meet any of the following criteria:
  • Participant has a personal or family history of aHUS
  • Participant has a history of malignant hypertension
  • Participant has a history of active cancer, excluding the haematological cancer for which the patient received the stem cell transplantation (if applicable)
  • The participant received prior complement inhibition
  • The participant received prior anti-interferon treatment
  • If applicable: Female who is pregnant, breast-feeding or intends to become pregnant the following year or is of child-bearing potential and not using an adequate, highly effective contraceptive
  • Participation in an interventional study with an investigational medicinal product (IMP) or device

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sofie A Dhaese, MD, PhD contact

+320050452200

sofie.dhaese@azsintjan.be

Belgium3 sites, 3 recruiting

  • AZ Sint-Jan Brugge AV

    Bruges, West-Vlaanderen, 8000

    Sofie AM Dhaese, MD, PhD, sofie.dhaese@azsintjan.be

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

    Steven Van Laecke, MD, PhD, steven.vanlaecke@uzgent.be

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, Vlaams-Brabant, 3000

    Kathleen Claes, MD, PhD, kathleen.claes@uzleuven.be

    Recruiting

Other trials in Belgium

About this study

Official title: The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy (ROSARIO)

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.

Read more

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.

Being tested
blood draw, urine collection
Keywords
thrombotic microangiopathy, secondary thrombotic microangiopathy, transplantation-associated thrombotic microangiopathy
Medical subject headings
Thrombotic Microangiopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood drawOther

    blood sampling at designated time points

  • urine collectionOther

    urine collection at designated time points

Study groups in NCT07705789
Study groupRoleWhat they receive
Patients with HSCT-TMA or SOT-TMAOtherblood and urine collection
Receives: Other: blood draw; Other: urine collection
Patients after HSCT or SOT with a viral infection, without TMAOtherblood and urine collection
Receives: Other: blood draw; Other: urine collection
Patients after HSCT or SOT without a viral infection, without TMAOtherblood and urine collection
Receives: Other: blood draw; Other: urine collection
Patients with drug-induced TMA (DITMA)Otherblood and urine collection
Receives: Other: blood draw; Other: urine collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interferon signature

    6-gene interferon signature

    Measured: Time point 1: baseline Time point 2: up to week 52

  2. VEGF-A

    VEGF-A level

    Measured: Time point 1: baseline Time point 2: up to week 52

  3. Complement analysis (serum)

    CH50, AP50, C3, C3d, C4 and C5b-9 at timepoint 1 and C5b-9 at time point 2

    Measured: Time point 1: baseline Time point 2: up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start15 Sep 2026
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705789
Sponsor's protocol ID
ROSARIO
Acronym
ROSARIO
Status last verified
Oct 2026
First submitted
19 Jun 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing blood draw and urine collection in people with Thrombotic Microangiopathies, run by Sofie Dhaese at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofie A Dhaese, MD, PhD (+320050452200, sofie.dhaese@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interferon signature (time frame: Time point 1: baseline Time point 2: up to week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in