Role of Interferon and Complement in Second-ary Thrombotic Microangiopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study investigates how high interferon levels and complement activation may contribute to endothelial damage in thrombotic microangiopathy after transplantation or other transplant-related contexts. Blood and urine samples are collected to measure interferon, VEGF-A, and markers of complement activity. The goal is to see if interferon plays a driving role in TA-TMA beyond known complement dysregulation. It will focus on biopsy-proven or clinically diagnosed TA-TMA and compare IFN levels with TMA outcomes. Participants are adults undergoing HSCT, solid organ transplantation, or diagnosed with DITMA, with specific clinical criteria used to identify TMA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. 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):

1. Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation OR patients with DITMA AND
2. Tissue diagnosis of TMA (pathological diagnosis) OR
3. 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):

1. Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
2. Symptomatic viral infection (evaluated by the treating physician).

Specifically for the group of patients without TMA, without infection (G3):

1. Patients after allogeneic or autologous hematopoietic stem cell transplantation (HSCT) OR patients after solid organ transplantation AND
2. No symptomatic viral infection (evaluated by the treating physician).

Exclusion Criteria:

Participants eligible for this study must not meet any of the following criteria:

1. Participant has a personal or family history of aHUS
2. Participant has a history of malignant hypertension
3. Participant has a history of active cancer, excluding the haematological cancer for which the patient received the stem cell transplantation (if applicable)
4. The participant received prior complement inhibition
5. The participant received prior anti-interferon treatment
6. 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
7. Participation in an interventional study with an investigational medicinal product (IMP) or device

Where it's running

• Universitair Ziekenhuis Gent
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• Universitair Ziekenhuis Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting
• AZ Sint-Jan Brugge AV
  Bruges, West-Vlaanderen, Belgium Recruiting

Study contacts

• Study coordinator: Sofie A Dhaese, MD, PhD
• Email: sofie.dhaese@azsintjan.be
• Phone: +320050452200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes for people with immune TTP in the French national TMA cohort

  This project uses past medical records to see long-term health outcomes and complications in people in France who had immune thrombotic thrombocytopenic purpura (iTTP).

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• Observational study of blood clotting and bleeding disorders in Chinese patients

  This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality and 4 other locations · NCT06727669

• Immunosuppression and caplacizumab with plasma infusion instead of plasma exchange for immune TTP

  This study tests whether adults with immune-mediated TTP can be treated safely and effectively with immunosuppression and caplacizumab plus plasma infusion without daily plasma exchange.

  Recruiting at 24 sites University Hospital, Rouen · Amiens and 29 other locations · NCT06291025

• Identifying blood markers for early diagnosis of transplant-related complications

  This study is trying to find blood markers that can help doctors spot early signs of a serious complication called TA-TMA in patients who have had a stem cell transplant.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT06102694

• Evaluating narsoplimab for treating TMA in children after stem cell transplants

  This study is testing a new treatment called narsoplimab to see if it can help children who are at high risk for blood vessel problems after getting stem cell transplants.

  Recruiting at 4 sites Phase 2 Omeros Corporation · San Diego, California and 15 other locations · NCT05855083

• Creating a database for patients with thrombotic microangiopathies

  This study is creating a detailed database to collect important information about patients with thrombotic microangiopathies to help improve understanding and treatment of the condition.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT05634928

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.