Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biological samples collection

    Biological/Vaccine

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
yearly and up to 10 years after inclusion in the study

Secondary outcomes

1

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%

Time frame
up to 10 years after inclusion in the study
2

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

Time frame
up to 10 years after inclusion in the study
3

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

Time frame
up to 10 years after inclusion in the study

Other outcomes

Sponsors and contacts

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