NCT03582436: KTD-innov

Rejection Diagnosis in Kidney Transplants Patients

Completed Last updated 10 February 2022

What this trial tests

trial testing Kidney transplantation in Kidney Transplantation in 824 participants. Completed in 18 March 2021.

Timeline

25 June 2018

Primary endpoint
18 March 2021

18 March 2021

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Completed
Study type	OBSERVATIONAL
Enrollment	824
Start date	25 June 2018
Primary completion	18 March 2021
Estimated completion	18 March 2021
Sites	1 location across France

Drugs / interventions tested

• Kidney transplantation

Conditions studied

• Kidney Transplantation — all drugs for Kidney Transplantation →
• Transplant Rejection — all drugs for Transplant Rejection →
• Graft Survival — all drugs for Graft Survival →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Kidney Transplantation or Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The transformative potential of artificial intelligence in solid organ transplantation.
   Al Moussawy M, Lakkis ZS, Ansari ZA, Cherukuri AR, et al · · 2024 · cited 15× · PMID 38993779 · DOI 10.3389/frtra.2024.1361491
2. Design, cohort profile and comparison of the KTD-Innov study: a prospective multidimensional biomarker validation study in kidney allograft rejection.
   Goutaudier V, Sablik M, Racapé M, Rousseau O, et al · · 2024 · cited 6× · PMID 38625480 · DOI 10.1007/s10654-024-01112-w
3. Detection of Kidney Allograft Rejection Using Urinary Chemokines.
   Goutaudier V, Aubert O, Racapé M, Truchot A, et al · · 2025 · cited 3× · PMID 40504617 · DOI 10.1681/asn.0000000742
4. Novel Biomarkers for Rejection in Kidney Transplantation: A Comprehensive Review.
   Strader M, Kant S. · · 2025 · cited 1× · PMID 40807111 · DOI 10.3390/jcm14155489
5. Antibody Mediated Rejection and T-cell Mediated Rejection Molecular Signatures Using Next-Generation Sequencing in Kidney Transplant Biopsies.
   Cortes Garcia E, Giarraputo A, Racapé M, Goutaudier V, et al · · 2024 · cited 1× · PMID 39050190 · DOI 10.3389/ti.2024.13043
6. Predicting long-term kidney graft failure using novel multi-omic blood-based biomarkers and artificial intelligence tools.
   Batko K, Małyszko J, Sączek A, Sobczyńska K, et al · · 2025 · PMID 40592302 · DOI 10.1159/000547039