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

NCT ID: NCT05318196

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2032-09-01

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.

Conditions

Acute Kidney Injury; Chronic Kidney Diseases; Solid-organ Transplantation; Cancer; Metabolic Disease; Immune Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislas Faguer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Rangueil University Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stanislas Faguer, MD, PhD

Role: CONTACT

faguer.s@chu-toulouse.fr

561322475 ext. 0033

Facility Contacts

Stanislas Faguer, MD, PhD

Role: primary

faguer.s@chu-toulouse.fr

561322475 ext. 0033

Other Identifiers

RC31/21/0154

Identifier Type: -

Identifier Source: org_study_id