About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
consent deny
inability of the patient or its family to give consent.
Trial population
Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions
Trial design
Cohort
Prospective
Treatments tested in this trial
Biological samples collection
Biological/VaccineSOT 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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%
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
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
Sponsors and contacts
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