NL-OMON54987
Recruiting
Not Applicable
The COMplement Prospective Evaluation of Thrombotic microangiopathy on Endothelium (COMPETE) Study - COMPETE
Medisch Universitair Ziekenhuis Maastricht0 sites42 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- atypical hemolytic uremic syndrome
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 42
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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:
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
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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