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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • blood draw

    Other intervention

    blood sampling at designated time points

  • urine collection

    Other intervention

    urine collection at designated time points

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Patients with HSCT-TMA or SOT-TMAOther 2 interventions
Group B: Patients after HSCT or SOT with a viral infection, without TMAOther 2 interventions
Group C: Patients after HSCT or SOT without a viral infection, without TMAOther 2 interventions
Group D: Patients with drug-induced TMA (DITMA)Other 2 interventions

Trial outcomes

Primary outcomes

1

Interferon signature

6-gene interferon signature

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

VEGF-A

VEGF-A level

Time frame
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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: