The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy
ConditionThrombotic Microangiopathies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSofie Dhaese
About this trial
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.
Eligibility criteria
Qualifiers
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)
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- blood draw
- urine collection
Treatment groups
40 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Sofie Dhaese
Lead sponsor
AZ Sint-Jan AV
Sponsor institution
AZ Sint-Jan AV
Collaborator
University Hospital, Ghent
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov