French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy" (MATRIX)

August 10, 2023 updated by: University Hospital, Tours

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Their epidemiology has recently been elucidated thanks to work published by our team. 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, many epidemiologic problems remain. First, many but not all patients with TMA as classically defined (mechanical anemia, thrombocytopenia, elevated LDH, decreased haptoglobin, schizocytes) have impaired renal function. If a renal biopsy is performed (which is not always the case, as TMA is a risk factor for bleeding after renal biopsy), the renal lesions do not always show "renal-limited" TMA. We also do not know which of the causes of systemic TMA are associated with renal TMA and which are not.

Conversely, in patients with renal biopsy, we can find stigmata of renal-limited TMA in the absence of systemic TMA. Why do some patients have systemic TMA but not renal TMA and others have renal TMA but not systemic TMA? Most studies are based on a few small clinical cases and the literature reviews that report them.

The vital, renal, and cardiovascular prognosis of patients with TMA obviously depends on the cause, the clinical presentation of the patients, and their management. However, the renal, systemic, and vital outcomes of renal-only vs. systemic-only vs. systemic and renal TMA, regardless of the cause and severity of TMA, are currently unknown.

As this is a rare disease, only a multicenter approach (>20 centers) over a long period of time (>10 years), including highly recruited university and general hospitals, with experienced and motivated investigators, can help us to answer these currently unanswered questions (these investigators usually belong to the competence centers of the national reference center).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Tours, France, 37044
        • Recruiting
        • Department of Nephrology, University Hospital of Tours
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MATRIX
Thrombotic microangiopathy with kidney biopsy
Other: Collecting datas
Blood, Tissue and Urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of isolated renal, hematological or renal associated with hematological features ot thrombotic microangiopathies
Time Frame: 1/ Baseline, ie date of kidney biopsy
Clinical data
1/ Baseline, ie date of kidney biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess correlations between specific anatomopathological lesions and thrombotic microangiopathies phenotypes
Time Frame: 1/ Baseline, ie date of kidney biopsy
Pathological and clinical data
1/ Baseline, ie date of kidney biopsy
Assess correlations between cause of thrombotic microangiopathies and clinical phenotypes
Time Frame: 1/ Baseline, ie date of kidney biopsy
Clinical data
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.
Time Frame: 1/ Up to 2 weeks after baseline date ; 2/ Date of last follow-up, an average of 2 years
Biological data
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
Time Frame: 1/ Hospital discharge date, an average of 2 weeks ; 2/ Date of last follow-up, an average of 2 years
Clinical data
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
Time Frame: 1/ Hospital discharge date, an average of 2 weeks
Clinical data
1/ Hospital discharge date, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Jean-Michel Halimi, MD, PhD, CHRU TOURS, Nephrology
  • Principal Investigator: Valentin Maisons, MD, CHRU TOURS, Nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI/MATRIX
  • F20221110095846 (Registry Identifier: CNIL)
  • 2022-59 (Ethique CVL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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