The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy
ROSARIO
1 other identifier
interventional
40
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
Study Completion
Last participant's last visit for all outcomes
December 31, 2031
July 15, 2026
July 1, 2026
5.3 years
June 19, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Interferon signature
6-gene interferon signature
Time point 1: baseline Time point 2: up to week 52
VEGF-A
VEGF-A level
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 point 1: baseline Time point 2: up to week 52
Study Arms (4)
Patients with HSCT-TMA or SOT-TMA
OTHERblood and urine collection
Patients after HSCT or SOT with a viral infection, without TMA
OTHERblood and urine collection
Patients after HSCT or SOT without a viral infection, without TMA
OTHERblood and urine collection
Patients with drug-induced TMA (DITMA)
OTHERblood and urine collection
Interventions
blood sampling at designated time points
urine collection at designated time points
Eligibility Criteria
You may qualify if:
- 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
- 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
- +9 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sofie Dhaeselead
- AZ Sint-Jan AVcollaborator
- University Hospital, Ghentcollaborator
- Universitaire Ziekenhuizen KU Leuvencollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 19, 2026
First Posted
July 15, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
July 15, 2026
Record last verified: 2026-07