Acute Kidney InjuryNEPHROGENE2NCT05318196
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases, Solid-organ Transplantation
- What is being tested?
- Biological samples collection
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 1 Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions
Who may be able to join
- Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease,
- Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)
Who cannot join
- consent deny
- inability of the patient or its family to give consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rangueil University Hospital
Toulouse, 31059
Stanislas Faguer, MD, PhD, 561322475 ext. 0033, faguer.s@chu-toulouse.fr
About this study
Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.
Read the detailed description
Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9).
The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders).
Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer…). Samples will be collected according to the symptoms of the patients.
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Solid-organ Transplantation, Cancer, Metabolic Disease, Immune Diseases
- Being tested
- Biological samples collection
- Keywords
- risk stratification, solid-organ transplantation, cancer, Chronic kidney disease, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Neoplasms, Metabolic Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collectionBiological
SOT patients: samples will be collected at the time of the protocol follow-up visit (registration on the transplant list, on the day of the transplantation, and then at day 15, month 1-3-6-9-12 and then annually, as well as if complications or therapeutic modifications).
Dialysis patients: at the start of the dialysis and then at M3, M12, and if complications or modification of the dialysis protocol.
Non-dialysis or cancer patients: the sampling frequency will be individualized according to the pathology studied (acute or chronic) and the purpose of the sampling (diagnostic, mechanistic, prediction, evaluation of the therapeutic response). Samples for diagnostic and mechanistic purposes will be taken only once. Samples for prognostic purposes will be taken at regular intervals, adapted to the natural history of the disease while respecting the maximum volume of blood samples defined by the French law. Samples will be collected during a sampling performed as part of routine care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases.
To identify the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. An unbiased multi-omic approach (including peptidomics, metabolomics, genome sequencing, and flow cytometry and transcriptomic of circulating immune cells) will be performed at the inclusion in the study and correlated to specific end-points (acute kidney injury, kidney failure progression, end-stage kidney disease, infection, cancer according to the underlying condition). Multiple measurements will be studied individually to identify genes variations, gene expression changes, urinary or plasma peptides abundance, immune cells relative abundance in the blood that correlate with the end-point. In a second step, an attempt to combine them in a single predictive signature using artificial intelligence approach.
Measured: yearly and up to 10 years after inclusion in the study
Secondary outcomes (3)
Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases
To identify the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases: end-points will be end-stage kidney disease, or a decrease of the estimated glomerular filtration rate (eGFR) > 50%
Measured: up to 10 years after inclusion in the study
Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases
To identify the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases: end-points will the development of bacterial, viral (CytoMégaloVirus, Herpes simplex virus, varicella-zoster virus, BK virus…) or fungal (candidiasis, aspergillosis…) infections, as well as cardiovascular events or other complications
Measured: up to 10 years after inclusion in the study
To specify the individual risk of complications secondary to SOT or its treatment
To specify the individual risk of renal and immunological complications secondary to cancer or hematological malignancies, or their treatments: end points will be the development of acute kidney injury, end-stage kidney disease or >50% reduction of the eGFR
Measured: up to 10 years after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start5 Sep 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Faguer, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318196
- Sponsor's protocol ID
- RC31/21/0154
- Acronym
- NEPHROGENE2
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
- ClinicalTrials.gov ID
- NCT05318196
- Acronym / sponsor ID
- NEPHROGENE2 / RC31/21/0154
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Solid-organ Transplantation, Cancer, Metabolic Disease, Immune Diseases
- Keywords
- risk stratification, solid-organ transplantation, cancer, Chronic kidney disease, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 8 Apr 2022 (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.
Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.
Detailed description
Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9).
The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders).
Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer…). Samples will be collected according to the symptoms of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions
Key inclusion criteria (2 listed)
- Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease,
- Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)
Key exclusion criteria (2 listed)
- consent deny
- inability of the patient or its family to give consent.
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 |
|---|---|---|
| Biological samples collectionSOT patients: samples will be collected at the time of the protocol follow-up visit (registration on the transplant list, on the day of the transplantation, and then at day 15, month 1-3-6-9-12 and then annually, as well as if complications or therapeutic modifications). Dialysis patients: at the start of the dialysis and then at M3, M12, and if complications or modification of the dialysis protocol. Non-dialysis or cancer patients: the sampling frequency will be individualized according to the pathology studied (acute or chronic) and the purpose of the sampling (diagnostic, mechanistic, prediction, evaluation of the therapeutic response). Samples for diagnostic and mechanistic purposes will be taken only once. Samples for prognostic purposes will be taken at regular intervals, adapted to the natural history of the disease while respecting the maximum volume of blood samples defined by the French law. Samples will be collected during a sampling performed as part of routine care. | Biological | – |
Primary outcome
Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases.
Time frame: yearly and up to 10 years after inclusion in the study
To identify the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. An unbiased multi-omic approach (including peptidomics, metabolomics, genome sequencing, and flow cytometry and transcriptomic of circulating immune cells) will be performed at the inclusion in the study and correlated to specific end-points (acute kidney injury, kidney failure progression, end-stage kidney disease, infection, cancer according to the underlying condition). Multiple measurements will be studied individually to identify genes variations, gene expression changes, urinary or plasma peptides abundance, immune cells relative abundance in the blood that correlate with the end-point. In a second step, an attempt to combine them in a single predictive signature using artificial intelligence approach.
3 secondary outcomes
Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases
Time frame: up to 10 years after inclusion in the study
Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases
Time frame: up to 10 years after inclusion in the study
To specify the individual risk of complications secondary to SOT or its treatment
Time frame: up to 10 years after inclusion in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Stanislas Faguer, MD, PhD principal investigator
University Hospital, Toulouse
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 Acute Kidney Injury and Chronic Kidney Diseases, run by University Hospital, Toulouse 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanislas Faguer, MD, PhD (561322475 ext. 0033, faguer.s@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. (time frame: yearly and up to 10 years after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.