Thrombotic MicroangiopathyMATRIXNCT05991245
French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
An observational study of Thrombotic Microangiopathy and Acute Kidney Injury, run by University Hospital, Tours at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Microangiopathy, Acute Kidney Injury, Hemolytic Uremic Syndrome
- What is being tested?
- Collecting datas
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 1. Kidney transplantation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Nephrology, University Hospital of Tours
Tours, 37044
Jean-Michel Halimi, MD,PhD, 02.47.47.37.46 ext. +33, jmhalimi@univ-tours.fr
Valentin Maisons, MD, 02.47.47.37.46 ext. +33, valentin.maisons@univ-tours.fr
About this study
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).
Read the 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).
- Conditions
- Thrombotic Microangiopathy, Acute Kidney Injury, Hemolytic Uremic Syndrome, Nephrology, Kidney Diseases
- Being tested
- Collecting datas
- Keywords
- Thrombotic microangiopathy, Acute kidney injury, Hemolytic uremic syndrome, Kidney histology, Complement
- Medical subject headings
- Thrombotic Microangiopathies, Acute Kidney Injury, Hemolytic-Uremic Syndrome, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting datasOther
Blood, Tissue and Urine samples
| Study group | Role | What they receive |
|---|---|---|
| MATRIX | Thrombotic microangiopathy with kidney biopsy Receives: Other: Collecting datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of isolated renal, hematological or renal associated with hematological features ot thrombotic microangiopathies
Clinical data
Measured: 1/ Baseline, ie date of kidney biopsy
Secondary outcomes (5)
Assess correlations between specific anatomopathological lesions and thrombotic microangiopathies phenotypes
Pathological and clinical data
Measured: 1/ Baseline, ie date of kidney biopsy
Assess correlations between cause of thrombotic microangiopathies and clinical phenotypes
Clinical data
Measured: 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.
Biological data
Measured: 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
Clinical data
Measured: 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
Clinical data
Measured: 1/ Hospital discharge date, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thrombotic MicroangiopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Halimi, MD, PhD, Study director, CHRU TOURS, NephrologyValentin Maisons, MD, Principal investigator, CHRU TOURS, Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991245
- Sponsor's protocol ID
- RNI/MATRIX
- Other IDs
- F20221110095846, 2022-59
- Acronym
- MATRIX
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27989322Bayer 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.
PubMed 30862697Genest 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.
PubMed 36509342Halimi 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.
PubMed 40630316
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
- ClinicalTrials.gov ID
- NCT05991245
- Acronym / sponsor ID
- MATRIX / RNI/MATRIX
- Conditions
- Thrombotic Microangiopathy, Acute Kidney Injury, Hemolytic Uremic Syndrome, Nephrology, Kidney Diseases
- Keywords
- Thrombotic microangiopathy, Acute kidney injury, Hemolytic uremic syndrome, Kidney histology, Complement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MATRIX | – | Other: Collecting datasThrombotic microangiopathy with kidney biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 1. Kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting datasBlood, Tissue and Urine samples | Other | MATRIX |
Primary outcome
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
5 secondary outcomes
Assess correlations between specific anatomopathological lesions and thrombotic microangiopathies phenotypes
Time frame: 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
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
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
Define treatments for these patients
Time frame: 1/ Hospital discharge date, an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 27989322Goodship 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.
- Background: PubMed 30862697Bayer 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.
- Background: PubMed 36509342Genest 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.
- Derived from this study: PubMed 40630316Halimi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Halimi, MD, PhD study director
CHRU TOURS, Nephrology
Valentin Maisons, MD principal investigator
CHRU TOURS, Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Microangiopathy and Acute Kidney Injury, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Michel Halimi, MD, PhD (02.47.47.37.46 ext. +33, jmhalimi@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of isolated renal, hematological or renal associated with hematological features ot thrombotic microangiopathies (time frame: 1/ Baseline, ie date of kidney biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991245, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.