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The COMplement Prospective Evaluation of Thrombotic microangiopathy on Endothelium (COMPETE) Study

The COMplement Prospective Evaluation of Thrombotic microangiopathy on Endothelium (COMPETE) Study - COMPETE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54987
Enrollment
42
Registered
2020-12-23
Start date
2021-08-13
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atypical hemolytic uremic syndrome, thrombotic microangiopathy

Interventions

Blood, urine, and clinical data. No intervention applicable.

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Males or females at least 18 years of age; - Have acute kidney injury, defined as estimated GFR 500 U/L, and either schistocytes on peripheral blood smear or undetectable haptoglobin), and platelets 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.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 ADAMTS13 deficiency, defined as ADAMTS13 activity

Design outcomes

Primary

MeasureTime frame
The prevalence of C-TMA in patients presenting with TMA, either with coexisting conditions or not.

Secondary

MeasureTime frame
The secondary parameters are based on the clinical course of disease, including hematologic and renal response, refractory TMA, renal recovery, chronic kidney disease, end-stage kidney disease, and death.

Countries

Netherlands

Contacts

Public ContactS.A.M.E.G. Timmermans

Maastricht Universitair Medisch Centrum +

sjoerd.timmermans@mumc.nl043-3871198

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026