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

NCT05318196 | Recruiting

• 1 other identifier: RC31/21/0154
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  yearly and up to 10 years after inclusion in the study

Secondary Outcomes (3)

• Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases

  up to 10 years after inclusion in the study

• Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases

  up to 10 years after inclusion in the study

• To specify the individual risk of complications secondary to SOT or its treatment

  up to 10 years after inclusion in the study

Interventions

Biological samples collection BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Rangueil University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Neoplasms; Metabolic Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Stanislas Faguer, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanislas Faguer, MD, PhD

CONTACT

561322475; faguer.s@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: September 5, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2032
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)