Clinical trial

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

Name

RC31/21/0154

Description

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.

Trial arms

Trial start

2022-09-05

Estimated PCD

2027-09-01

Trial end

2032-09-01

Status

Recruiting

Treatment

Biological samples collection

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.

Size

5000

Primary endpoint

Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases.

yearly and up to 10 years after inclusion in the study

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 5000, 'type': 'ESTIMATED'}}

Updated at

2024-03-29

1 organization

1 product

6 indications

Organization

University Hospital of Toulouse

Product

Biological samples collection

Indication

Acute Kidney Injury

Indication