Acute Kidney Injury Clinical Trial
— MATRIXOfficial title:
French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Progress has been made regarding the epidemiology of TMA (Bayer CJASN 2019). It has been shown that secondary TMAs account for 95% of cases, whereas primary TMAs (atypical hemolytic syndromes (HUS) and thrombotic thrombocytopenic purpura (TTP)) account for only about 5%. However, in many cases, the pathophysiology, optimal management and prognosis of TMA remains unclear and it has been shown that patients with TMA may have renal-limited TMA or renal and hematological TMA (ie. With (mechanical anemia, thrombocytopenia, elevated LDH, decreased haptoglobin, schistocytes). In most studies, kidney biopsies are not performed and the diagnostic workup is uncomplete. As this is a rare disease, only a multicenter approach (>20 centers) over a long period of time (>10 years), with adequate diagnostic workup including kidney biopsies can help us to answer these questions (investigators in the present are usually members of the CNR-MAT (a network of the TMA centers in France).
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients 18 years of age or older 2. Who have undergone renal biopsy of the native kidney for impaired renal function between 2009 and July 2022. 3. Presence of classically defined systemic MAT (most of the following parameters: elevated LDH, decreased haptoglobin, schizocytes, thrombocytopenia and anemia) AND/OR presence of arteriolar or glomerular renal MAT as indicated by the pathologist (including endothelial turgor, mesangiolysis, double contours, presence of thrombi, fibrinoid necrosis of the arterial wall). Exclusion Criteria: 1. Kidney transplantation |
Country | Name | City | State |
---|---|---|---|
France | Department of Nephrology, University Hospital of Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Bayer G, von Tokarski F, Thoreau B, Bauvois A, Barbet C, Cloarec S, Merieau E, Lachot S, Garot D, Bernard L, Gyan E, Perrotin F, Pouplard C, Maillot F, Gatault P, Sautenet B, Rusch E, Buchler M, Vigneau C, Fakhouri F, Halimi JM. Etiology and Outcomes of Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):557-566. doi: 10.2215/CJN.11470918. Epub 2019 Mar 12. — View Citation
Genest DS, Patriquin CJ, Licht C, John R, Reich HN. Renal Thrombotic Microangiopathy: A Review. Am J Kidney Dis. 2023 May;81(5):591-605. doi: 10.1053/j.ajkd.2022.10.014. Epub 2022 Dec 10. — View Citation
Goodship TH, Cook HT, Fakhouri F, Fervenza FC, Fremeaux-Bacchi V, Kavanagh D, Nester CM, Noris M, Pickering MC, Rodriguez de Cordoba S, Roumenina LT, Sethi S, Smith RJ; Conference Participants. Atypical hemolytic uremic syndrome and C3 glomerulopathy: conclusions from a "Kidney Disease: Improving Global Outcomes" (KDIGO) Controversies Conference. Kidney Int. 2017 Mar;91(3):539-551. doi: 10.1016/j.kint.2016.10.005. Epub 2016 Dec 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of isolated renal, hematological or renal associated with hematological features ot thrombotic microangiopathies | Clinical data | 1/ Baseline, ie date of kidney biopsy | |
Secondary | Assess correlations between specific anatomopathological lesions and thrombotic microangiopathies phenotypes | Pathological and clinical data | 1/ Baseline, ie date of kidney biopsy | |
Secondary | Assess correlations between cause of thrombotic microangiopathies and clinical phenotypes | Clinical data | 1/ Baseline, ie date of kidney biopsy | |
Secondary | Define the biological profile (standard biology and alternative complement pathway analyses including genetic data) of these thrombotic microangiopathies. | Biological data | 1/ Up to 2 weeks after baseline date ; 2/ Date of last follow-up, an average of 2 years | |
Secondary | Define the renal, cardiovascular and vital prognosis of these patients | Clinical data | 1/ Hospital discharge date, an average of 2 weeks ; 2/ Date of last follow-up, an average of 2 years | |
Secondary | Define treatments for these patients | Clinical data | 1/ Hospital discharge date, an average of 2 weeks |
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