NCT04745195Recruiting
Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium
Diagnostic and Risk Criteria for Complement Defects in Thrombotic Microangiopathy and Amplifying Conditions, Such as Severe Hypertension: The COMPETE Study.
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Thrombotic microangiopathy (TMA) is a severe and life-threatening condition, often affecting the kidneys and brain. It can occur on the background of various clinical conditions. Dysregulation of the alternative pathway of complement may be the etiological factor and this type of TMA is classified, according to the current nomenclature, as primary atypical hemolytic uremic syndrome (HUS). Half the patients with primary atypical HUS present with rare variants in complement genes, although coexisting conditions are often needed for the TMA to become manifest. In patients with secondary atypical HUS, certain coexisting conditions appear to drive the disease and treatment should target the underlying condition to remit the TMA. Recently, the investigators demonstrated, by using a novel in-house developed functional endothelial cell-based test, that complement dysregulation and overactivation is the dominant cause of disease and its sequelae in a subset of patients with secondary atypical HUS, having impact on treatment and prognosis. The investigators did first prove this concept in patients presenting with TMA and hypertensive emergency. A prospective study is needed to further corroborate these findings along the spectrum of TMA. The investigators hypothesize that their functional endothelial cell-based test, the so-called "HMEC" test, can better categorizes the TMA into different groups with potential therapeutic and prognostic implications. Thus, paving the road to the ultimate goal of precision medicine.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 42 (estimated)
- First submitted
- 6 Jan 2021
- Start date
- 11 Aug 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- High blood pressure
- NCT number
- NCT04745195
What you commit to
- Study type: Observational
- Planned participants: 42
- From 11 Aug 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received at least one of the following agents: chemotherapeutics, sirolimus, anti-VEGF agents;
Other illness
- Have secondary causes of hypertensive emergency, including renovascular hypertension, Cushing syndrome, aldosteronism, pheochromocytoma, thyroid disease;
- Have a nephropathy not related to thrombosis on kidney biopsy;
- Have positive serologic test for viral infections, including HIV and CMV;
- Have a history of malignant disease, excluding non-melanoma skin cancer;
- Have a history of bone marrow or solid organ transplantation, excluding kidney transplantation;
- Have a history of recent past exposure to illicit drug(s).
Other
- Have ADAMTS13 deficiency, defined as ADAMTS13 activity \<10%;
- Have a positive stool culture for Shiga toxin producing bacteria;
Who the study is looking for
- Males or females at least 18 years of age;
- Have acute kidney injury, defined as estimated GFR \<45 mL/min/1.73m2;
- Have documented TMA either on peripheral blood, defined as Coombs negative microangiopathic hemolytic anemia (hematocrit \<30%, hemoglobin \<6.5 mmol/L \[\<10 g/dL\], lactate dehydrogenase \>500 U/L, and either schistocytes on peripheral blood smear or undetectable haptoglobin), and platelets \<150,000 per µL, or kidney biopsy;
- Have primary atypical HUS or a coexisting condition linked to complement dysregulation:
- Hypertensive emergency, defined as SBP/DBP of \>180/120 mmHg and impending organ damage secondary to hypertension (at least one of the following: neurologic disease, hypertensive retinopathy grade III and/or IV, left ventricular hypertrophy); OR
- Pregnancy, including 12 weeks postpartum; OR
- Kidney donor recipient; OR
- Systemic auto-immune disease associated with TMA, including systemic sclerosis, systemic lupus erythematosus, anti-phospholipid syndrome;
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.