The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy (NCT07705789) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Role of interferOn and Complement in SecondAry thRombotic micrioangiOpathy
40 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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)
. 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):
. Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interferon signature
Timeframe: Time point 1: baseline Time point 2: up to week 52
2
VEGF-A
Timeframe: Time point 1: baseline Time point 2: up to week 52
3
Complement analysis (serum)
Timeframe: Time point 1: baseline Time point 2: up to week 52
. Symptomatic viral infection (evaluated by the treating physician).
. Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
Exclusion 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