Clinical trial NCT05318196: Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Official title: Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* consent deny
* inability of the patient or its family to give consent.

Primary outcomes:
measure: Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases.
timeFrame: yearly and up to 10 years after inclusion in the study
Secondary outcomes:
measure: Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases
timeFrame: up to 10 years after inclusion in the study
measure: Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases
timeFrame: up to 10 years after inclusion in the study
measure: To specify the individual risk of complications secondary to SOT or its treatment
timeFrame: up to 10 years after inclusion in the study
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Stanislas Faguer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: