BIOmarkers Before and After Kidney Transplantation

NCT06810258 | Recruiting

• 1 other identifier: APHP240374
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

In clinical nephrology, the search for urinary, blood and tissue biomarkers of specific kidney diseases is an important goal. In recent years, the use of these biomarkers has made it possible to diagnose many renal diseases that affect the native kidney. In some cases, biomarkers may be useful in determining the evolutionary profile of the disease and thus the most appropriate therapeutic management.

Conditions

Kidney Disease; Kidney Transplantation

Keywords

Biomarkers; Chronic kidney disease; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• The main aim of this study is to identify blood, urine and tissue biomarkers in kidney disease for diagnostic and prognostic purposes.

  the main criteria of interest for the analysis will include : * Exposure factors: blood and/or urine and/or tissue biomarkers * Diagnostic (presence or absence of the renal disease of interest) and prognostic (occurrence or absence of the event of interest) endpoints

  1 year

Secondary Outcomes (1)

• improve understanding of the pathophysiological mechanisms involved in the development of native kidney pathologies

  through study completion, an average of 1 year

Interventions

Blood sample during native kidney biopsy OTHER

blood sample during standard of care visit for a native kidney biopsy (17.5mL)

Blood sample during renal graft biopsy OTHER

blood sample during standard of care visit for a renal graft biopsy (17.5mL)

Urine sample during renal graft biopsy OTHER

Urine sample during standard of care visit for a renal graft biopsy (50mL)

Urine sample during native kidney biopsy OTHER

Urine sample during standard of care visit for a native kidney biopsy (50mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated in the nephrology and transplantation department of Henri Mondor Hospital who have had a biopsy of their native kidneys or renal graft or enlisted in the renal allograft waiting list

You may qualify if:

• Patient hospitalised for renal biopsy of a native kidney or for renal transplantation
• Age \>18 years
• Informed and consented
• Covered by a social security scheme

You may not qualify if:

• Patients under guardianship, conservatorship or legal protection
• Pregnant or breastfeeding
• Patient deprived of liberty
• Patients of legal age who are unable to give consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

One or two 50 mL urine tubes and 17.5 mL blood tubes are collected. The urine cell pellet is recovered from each sample by centrifugation and lysed according to a well-defined protocol established by the manufacturer and then stored at -80°C. * The PaXgen tube is left at room temperature for 2 hours according to the protocol and then stored at -20°C. * Serum is recovered after centrifugation of the dry tube at 4000 rpm for 10 minutes and stored at -80°C. * PBMC are extracted from the Cpt tube, frozen at 50% in SVF-10% DMSO and stored at -80°C. Depending on the study, mRNA expression is then analysed by quantitative PCR (targeted research) or microarray.

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marie Dr MATIGNON, MD, PhD

CONTACT

01-49-81-44-51; marie.matignon@aphp.fr

Vincent Pr AUDARD, MD, PhD

CONTACT

01 49 81 24 53; vincent.audard@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 5, 2025
• Study Start: October 8, 2024
• Primary Completion (Estimated): October 8, 2034
• Study Completion (Estimated): October 8, 2035
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

FR (1)