Criteria by Jodele et al for TA-TMA definition and resolution
| TA-TMA diagnosed by any tissue biopsy, or by ≥4 of 7 TA-TMA biomarkers being present∗ . | Resolution criteria† . | |
|---|---|---|
| 1 | LDH above normal value for age | LDH normal for age |
| 2 | Schistocytes on peripheral blood smear | Schistocytes are absent |
| 3 | De novo thrombocytopenia or require platelet transfusions | Not requiring platelet transfusion |
| 4 | De novo anemia or require RBC transfusions | Not requiring RBC transfusion |
| 5 | Hypertension of >99% for age (aged <18 y) or 140/90 (aged ≥18 y) or receiving antihypertensive therapy | Normotensive for age, on ≤2 antihypertensive medications |
| 6 | rUPCR of ≥1 mg/mg or patient is receiving RRT, if anuric | Resolution of proteinuria by rUPCR of <1 mg/mg |
| 7 | Terminal complement activation: elevated plasma sC5b-9 above normal limit of (≥244 ng/mL) | Normal sC5b-9 (<244 ng/mL) |
| TA-TMA diagnosed by any tissue biopsy, or by ≥4 of 7 TA-TMA biomarkers being present∗ . | Resolution criteria† . | |
|---|---|---|
| 1 | LDH above normal value for age | LDH normal for age |
| 2 | Schistocytes on peripheral blood smear | Schistocytes are absent |
| 3 | De novo thrombocytopenia or require platelet transfusions | Not requiring platelet transfusion |
| 4 | De novo anemia or require RBC transfusions | Not requiring RBC transfusion |
| 5 | Hypertension of >99% for age (aged <18 y) or 140/90 (aged ≥18 y) or receiving antihypertensive therapy | Normotensive for age, on ≤2 antihypertensive medications |
| 6 | rUPCR of ≥1 mg/mg or patient is receiving RRT, if anuric | Resolution of proteinuria by rUPCR of <1 mg/mg |
| 7 | Terminal complement activation: elevated plasma sC5b-9 above normal limit of (≥244 ng/mL) | Normal sC5b-9 (<244 ng/mL) |
RRT (includes continues RRT and/or dialysis).
LDH, lactate dehydrogenase; RBC, red blood cell.
Must have rUPCR of ≥1 mg/mg and elevated sC5b-9 for study eligibility; diagnostic biomarker requirements for study eligibility to meet high-risk TA-TMA criteria and for response assessment.4
Must be sustained for ≥14 days to be resolved.