Rejection Diagnosis in Kidney Transplants Patients

NCT03582436 | Completed

• 2 other identifiers: K170909J2018-A00090-55
• Study Type: observational
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients. the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.

Conditions

Kidney Transplantation; Transplant Rejection; Graft Survival

Keywords

Kidney; Allogeneic transplantation; Cohort study; Rejection; Biomarkers; Integrative medicine

Outcome Measures

Primary Outcomes (1)

• Concordance of invasive/non-invasive biomarkers with allograft rejection

  Concordance of invasive/non-invasive biomarkers with allograft rejection diagnosed by the gold standard (histology) in kidney transplant recipients.

  month 12

Secondary Outcomes (13)

• Association of non-invasive biomarkers with different subtypes of rejection

  month 12

• Association of gene sets with different subtypes of rejection in the biopsy.

  month 12

• Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection.

  month 12

• Variation of the non-invasive biomarker signature of allograft rejection

  month 12

• Variation of the gene set signature

  month 12

Study Arms (1)

Prospective cohort

Kidney transplantation

Procedure: Kidney transplantation

Interventions

Kidney transplantation PROCEDURE

For the patients with the kidney transplantation, these parameters will be analysis: Transcriptomics analysis Characteristics of anti HLA DSA analysis Non-HLA antibodies analysis Omics blood analysis Urine chemokines analysis

Also known as: Transcriptomics analysis, Non-HLA antibodies analysis, Omics blood analysis, Urine chemokines analysis,, Characteristics of anti HLA DSA analysis

Prospective cohort

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

New kidney transplants patients

You may qualify if:

• Men or female patients, Age ≥ 18 years old at the time of transplantation. Patients receiving a kidney transplant from a living or deceased donor. Patients who signed the informed consent form and willing to comply with study procedures.
• Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen
• Patients with a minimum weight of 40 kg

You may not qualify if:

• History of multi-organ transplant (interference with rejection natural history).
• Unable/unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native French speaker).
• Vulnerable participants (minors, protected adults, pregnant women, legally detained

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Saint-Louis

Paris, 75010, France

Location

Related Publications (2)

• Goutaudier V, Aubert O, Racape M, Truchot A, Sablik M, Raynaud M, Vicaut E, Rousseau O, Elias M, Divard G, Papuchon E, Danger R, Charreau B, Bouton D, Nguyen-Khoa T, Randoux-Lebrun C, Taupin JL, Gourraud PA, Giral M, Le Quintrec M, Morelon E, Couzi L, Legendre C, Lefaucheur C, Kamar N, Brouard S, Anglicheau D, Loupy A; KTD-Innov Consortium. Detection of Kidney Allograft Rejection Using Urinary Chemokines. J Am Soc Nephrol. 2025 Jun 12;36(11):2228-40. doi: 10.1681/ASN.0000000742. Online ahead of print.

  PMID: 40504617 DERIVED

• Goutaudier V, Sablik M, Racape M, Rousseau O, Audry B, Kamar N, Raynaud M, Aubert O, Charreau B, Papuchon E, Danger R, Letertre L, Couzi L, Morelon E, Le Quintrec M, Taupin JL, Vicaut E, Legendre C, Le Mai H, Potluri V, Nguyen TV, Azoury ME, Pinheiro A, Nouadje G, Sonigo P, Anglicheau D, Tieken I, Vogelaar S, Jacquelinet C, Reese P, Gourraud PA, Brouard S, Lefaucheur C, Loupy A; KTD-Innov Consortium. Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection. Eur J Epidemiol. 2024 May;39(5):549-564. doi: 10.1007/s10654-024-01112-w. Epub 2024 Apr 16.

  PMID: 38625480 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples, urines samples, kidney biopsy samples.

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Kidney Transplantation; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Genetic Techniques; Investigative Techniques

Study Officials

• Alexandre Loupy, Pr

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 11, 2018
• Study Start: June 25, 2018
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

FR (1)