NCT05991245

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

July 31, 2023

Last Update Submit

August 10, 2023

Conditions

Thrombotic MicroangiopathyAcute Kidney InjuryHemolytic Uremic SyndromeNephrologyKidney Diseases

Keywords

Thrombotic microangiopathyAcute kidney injuryHemolytic uremic syndromeKidney histologyComplement

Outcome Measures

Primary Outcomes (1)

  • Presence of isolated renal, hematological or renal associated with hematological features ot thrombotic microangiopathies

    Clinical data

    1/ Baseline, ie date of kidney biopsy

Secondary Outcomes (5)

  • Assess correlations between specific anatomopathological lesions and thrombotic microangiopathies phenotypes

    1/ Baseline, ie date of kidney biopsy

  • Assess correlations between cause of thrombotic microangiopathies and clinical phenotypes

    1/ Baseline, ie date of kidney biopsy

  • Define the biological profile (standard biology and alternative complement pathway analyses including genetic data) of these thrombotic microangiopathies.

    1/ Up to 2 weeks after baseline date ; 2/ Date of last follow-up, an average of 2 years

  • Define the renal, cardiovascular and vital prognosis of these patients

    1/ Hospital discharge date, an average of 2 weeks ; 2/ Date of last follow-up, an average of 2 years

  • Define treatments for these patients

    1/ Hospital discharge date, an average of 2 weeks

Study Arms (1)

MATRIX

Thrombotic microangiopathy with kidney biopsy

Other: Collecting datas

Interventions

Collecting datasOTHER

Blood, Tissue and Urine samples

MATRIX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population corresponds to French adult nephrology patients with renal and/or systemic thrombotic microangiopathy, for whom renal biopsy data are available. It is not extendable to renal transplant patients.

You may qualify if:

  • Adult patients 18 years of age or older
  • Who have undergone renal biopsy of the native kidney for impaired renal function between 2009 and July 2022.
  • 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).

You may not qualify if:

  • \. Kidney transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, University Hospital of Tours

Tours, 37044, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27989322BACKGROUND

  • 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.

    PMID: 30862697BACKGROUND

  • 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.

    PMID: 36509342BACKGROUND

  • Halimi JM, Duval A, Chardon E, Mesnard L, Frimat M, Fakhouri F, Grange S, Servais A, Cartery C, Coppo P, Titeca-Beauport D, Roger S, Baroukh N, Fage N, Delmas Y, Querard AH, Seret G, Bobot M, Le Quintrec M, Ville S, von Tokarski F, Chauvet S, Wynckel A, Martins M, Schurder J, Barbet C, Sautenet B, Gatault P, Caillard S, Antunes C, Bayer G, Philipponnet C, Audard V, Maillard N, Vuiblet V, Gnemmi V, El Ouafi Z, Canet S, Dekeyser M, Piver E, Maisons V; MATRIX Consortium Group. Diagnostic Value of Biological Parameters in Biopsy-Confirmed Thrombotic Microangiopathy-MATRIX Consortium Group. Kidney Int Rep. 2025 Mar 17;10(6):1950-1959. doi: 10.1016/j.ekir.2025.03.019. eCollection 2025 Jun.

    PMID: 40630316DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Tissue and Urine samples

MeSH Terms

Conditions

Thrombotic MicroangiopathiesAcute Kidney InjuryHemolytic-Uremic SyndromeKidney Diseases

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUremiaAnemia, HemolyticAnemia

Study Officials

  • Jean-Michel Halimi, MD, PhD

    CHRU TOURS, Nephrology

    STUDY DIRECTOR

  • Valentin Maisons, MD

    CHRU TOURS, Nephrology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Michel Halimi, MD, PhD

CONTACT

02.47.47.37.46jmhalimi@univ-tours.fr

Valentin Maisons, MD

CONTACT

02.47.47.37.46valentin.maisons@univ-tours.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 14, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

FR(1)