Actively Recruiting

Age: 18Years +
All Genders
ID04745195

Diagnostic and Risk Criteria for Complement Defects in Thrombotic Microangiopathy and Related Conditions Including Severe Hypertension: The COMPETE Study

Led by Maastricht University Medical Center · Updated on 2025-10-01

42

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Thrombotic microangiopathy (TMA) is a serious condition affecting the kidneys and brain, often linked to a problem in the complement system called primary atypical hemolytic uremic syndrome (HUS). This condition can arise from various clinical situations, and researchers believe that a new test called the "HMEC" test can better classify TMA types. This may help guide treatment and predict outcomes, moving toward more personalized care for patients with TMA. The study observes patients with different forms of TMA, including those with primary atypical HUS and secondary atypical HUS linked to other conditions like severe hypertension, pregnancy, or autoimmune diseases. Participants will be monitored using the HMEC test along with other routine measures to understand complement involvement. The study focuses on how complement dysregulation influences disease progression and response, without introducing new treatments. Participants will be followed for up to one year, with monthly blood tests and kidney function assessments to track disease course and complement activity. Researchers will measure the prevalence of complement-mediated TMA, kidney outcomes, and the accuracy of the HMEC test. The study aims to improve diagnosis and risk assessment for patients with TMA while ensuring safety through careful monitoring and data collection throughout the study period.

CONDITIONS

Brief Title

Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Acute kidney injury with estimated GFR less than 45 mL/min/1.73m2
  • Documented thrombotic microangiopathy confirmed by blood tests or kidney biopsy
  • Diagnosis of primary atypical hemolytic uremic syndrome (HUS) or related conditions such as hypertensive emergency, pregnancy up to 12 weeks postpartum, kidney donor recipient, or systemic autoimmune diseases associated with TMA
  • Ability to understand study requirements, provide consent, and follow study procedures
Not Eligible

You will not qualify if you...

  • Secondary causes of hypertensive emergency like renovascular hypertension, Cushing syndrome, aldosteronism, pheochromocytoma, or thyroid disease
  • Kidney disease unrelated to thrombosis on biopsy
  • ADAMTS13 deficiency with activity below 10%
  • Positive stool test for Shiga toxin-producing bacteria
  • Positive blood tests for viral infections including HIV and CMV
  • History of malignant diseases except non-melanoma skin cancer
  • History of bone marrow or solid organ transplantation except kidney transplantation
  • Previous use of certain drugs including chemotherapeutics, sirolimus, or anti-VEGF agents
  • Recent exposure to illicit drugs

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo diagnostic procedures to confirm thrombotic microangiopathy and related conditions.

Monthly visits for up to 1 year

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored over time to assess disease progression and kidney function outcomes.

Monthly visits for up to 1 year

Trial Site Locations

Total: 1 location

1

Maastricht University Medical Center

Maastricht, Limburg, Netherlands, 6229HX

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Research Team

S

Sjoerd A.M.E.G. Timmermans, MD, PhD

D

Daan P.C. van Doorn, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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