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

Recruiting

• Conditions: atypical hemolytic uremic syndrome; Thrombotic microangiopathy; 10018911; 10029149; 10014523

• Registration Number: NL-OMON54987
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 42

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 <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 C-TMA:
-- 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.

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 <10%;
- Have a positive stool culture for Shiga toxin producing bacteria;
- 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;
- Received at least one of the following agents: chemotherapeutics, calcineurin
inhibitors, sirolimus, anti-VEGF agents;
- Have a history of recent past exposure to illicit drug(s).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The prevalence of C-TMA in patients presenting with TMA, either with coexisting<br /><br>conditions or not. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters are based on the clinical course of disease, including<br /><br>hematologic and renal response, refractory TMA, renal recovery, chronic kidney<br /><br>disease, end-stage kidney disease, and death.</p><br>