NCT03652402

Brief Summary

Main objective: To design a precision risk stratification system that predicts individual risk of rejection

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

July 16, 2018

Last Update Submit

June 4, 2024

Conditions

Kidney Transplant RejectionKidney TransplantationRisk StratificationPrognosis

Keywords

KidneyAllogenic transplantationCohort studyRejectionBiomarkersResponse to treatmentIntegrative medicine

Outcome Measures

Primary Outcomes (1)

  • Capacity of non-invasive biomarkers and intragraft gene expression profiles combined to standard of care data (HLA system, clinical and biological data)

    Prognosis value of non-invasive biomarkers and intragraft gene expression profile changes combined to standard of care data changes (HLA system, clinical and biological data), to identify high versus low risk profiles of rejection as measured by DSA characteristics (Donor-Specific Antibody) by Luminex single antigen assay and non DSA characteristics by functional in vitro assay on endothelial targets, alloreactive T and B cells profiles by ELISPOT, blood mRNA expression by NanoString technologies and gene expression on DNA chips.

    Day 0, Month 3, Month 12, clinical indication over 12 months

Secondary Outcomes (6)

  • Correlation of blood biomarkers concentration with allograft rejection (rejection assessed by histopathology)

    Day 0, Month 3, Month12, clinical indication over 12 months

  • Correlation of blood biomarker concentrations with allograft function (function measured by the Glomerular Filtration Rate (GFR)).

    Day 0, Month 3, Month12, clinical indication over 12 months

  • Assessment of changes in biomarker levels in serial measurements and association with allograft function (function measured by the GFR)

    Day 0, Month 3, Month12, clinical indication over 12 months

  • Correlation of gene expression in kidney allografts with allograft rejection (rejection assessed by histopathology)

    Day 0, Month 3, Month 12, clinical indication over 12 months

  • Gene expression related risk stratification of response to treatment in kidney allograft rejection (rejection assessed by histopathology)

    Day 0, Month 3, Month12, clinical indication over 12 months

  • +1 more secondary outcomes

Interventions

kidney transplantationPROCEDURE

samples additional to the standard of care' (SOC)will be taken at each visit (Day 0, Month 3, Month12, clinical indication)

Also known as: Gene expression analysis in the biopsy, Non-HLA antibody analysis in the blood, Protein biomarker analysis in the blood, T and B cell analyses in the blood, mRNA in the blood

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

New kidney transplants patients

You may qualify if:

  • Men and women, Age ≥ 18 years old at the time of transplantation.
  • Patients receiving a living or deceased donor kidney allograft.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, Paris, 94270, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hopital Saint Louis

Paris, Île-de-France Region, 75010, France

Location

Hospital La Charité

Mitte, State of Berlin, 10117, Germany

Location

Hospital La Charité Campus Virchow

Berlin, 10117, Germany

Location

Hospital Bellvitge

Barcelona, 08907, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08907, Spain

Location

Hôpitaux Universitaires de Genève

Geneva, 4 CH 1211, Switzerland

Location

Related Publications (15)

  • Montero N, Farouk S, Gandolfini I, Crespo E, Jarque M, Meneghini M, Torija A, Maggiore U, Cravedi P, Bestard O. Pretransplant Donor-specific IFNgamma ELISPOT as a Predictor of Graft Rejection: A Diagnostic Test Accuracy Meta-analysis. Transplant Direct. 2019 Apr 25;5(5):e451. doi: 10.1097/TXD.0000000000000886. eCollection 2019 May.

    PMID: 31165086RESULT

  • Danger R, Feseha Y, Brouard S. The Pseudokinase TRIB1 in Immune Cells and Associated Disorders. Cancers (Basel). 2022 Feb 17;14(4):1011. doi: 10.3390/cancers14041011.

    PMID: 35205759RESULT

  • Brinas F, Danger R, Brouard S. TCL1A, B Cell Regulation and Tolerance in Renal Transplantation. Cells. 2021 Jun 1;10(6):1367. doi: 10.3390/cells10061367.

    PMID: 34206047RESULT

  • Danger R, Moiteaux Q, Feseha Y, Geffard E, Ramstein G, Brouard S. FaDA: A web application for regular laboratory data analyses. PLoS One. 2021 Dec 20;16(12):e0261083. doi: 10.1371/journal.pone.0261083. eCollection 2021.

    PMID: 34928943RESULT

  • Ba R, Geffard E, Douillard V, Simon F, Mesnard L, Vince N, Gourraud PA, Limou S. Surfing the Big Data Wave: Omics Data Challenges in Transplantation. Transplantation. 2022 Feb 1;106(2):e114-e125. doi: 10.1097/TP.0000000000003992.

    PMID: 34889882RESULT

  • Massart A, Danger R, Olsen C, Emond MJ, Viklicky O, Jacquemin V, Soblet J, Duerinckx S, Croes D, Perazzolo C, Hruba P, Daneels D, Caljon B, Sever MS, Pascual J, Miglinas M; Renal Tolerance Investigators; Pirson I, Ghisdal L, Smits G, Giral M, Abramowicz D, Abramowicz M, Brouard S. An exome-wide study of renal operational tolerance. Front Med (Lausanne). 2023 May 17;9:976248. doi: 10.3389/fmed.2022.976248. eCollection 2022.

    PMID: 37265662RESULT

  • Yoo D, Goutaudier V, Divard G, Gueguen J, Astor BC, Aubert O, Raynaud M, Demir Z, Hogan J, Weng P, Smith J, Garro R, Warady BA, Zahr RS, Sablik M, Twombley K, Couzi L, Berney T, Boyer O, Duong-Van-Huyen JP, Giral M, Alsadi A, Gourraud PA, Morelon E, Le Quintrec M, Brouard S, Legendre C, Anglicheau D, Villard J, Zhong W, Kamar N, Bestard O, Djamali A, Budde K, Haas M, Lefaucheur C, Rabant M, Loupy A. An automated histological classification system for precision diagnostics of kidney allografts. Nat Med. 2023 May;29(5):1211-1220. doi: 10.1038/s41591-023-02323-6. Epub 2023 May 4.

    PMID: 37142762RESULT

  • Ed-Driouch C, Mars F, Gourraud PA, Dumas C. Addressing the Challenges and Barriers to the Integration of Machine Learning into Clinical Practice: An Innovative Method to Hybrid Human-Machine Intelligence. Sensors (Basel). 2022 Oct 29;22(21):8313. doi: 10.3390/s22218313.

    PMID: 36366011RESULT

  • Kerouac S, Taggart ME, Lescop J, Fortin MF. Dimensions of health in violent families. Health Care Women Int. 1986;7(6):413-26. doi: 10.1080/07399338609515756. No abstract available.

    PMID: 3641838RESULT

  • Divard G, Raynaud M, Tatapudi VS, Abdalla B, Bailly E, Assayag M, Binois Y, Cohen R, Zhang H, Ulloa C, Linhares K, Tedesco HS, Legendre C, Jouven X, Montgomery RA, Lefaucheur C, Aubert O, Loupy A. Comparison of artificial intelligence and human-based prediction and stratification of the risk of long-term kidney allograft failure. Commun Med (Lond). 2022 Nov 23;2(1):150. doi: 10.1038/s43856-022-00201-9.

    PMID: 36418380RESULT

  • Tripathi N, Danger R, Chesneau M, Brouard S, Laurent AD. Structural insights into the catalytic mechanism of granzyme B upon substrate and inhibitor binding. J Mol Graph Model. 2022 Jul;114:108167. doi: 10.1016/j.jmgm.2022.108167. Epub 2022 Mar 22.

    PMID: 35366507RESULT

  • Danger R, Le Berre L, Cadoux M, Kerleau C, Papuchon E, Mai HL, Nguyen TV, Guerif P, Morelon E, Thaunat O, Legendre C, Anglicheau D, Lefaucheur C, Couzi L, Del Bello A, Kamar N, Le Quintrec M, Goutaudier V, Renaudin K, Giral M, Brouard S; DIVAT Consortium. Subclinical rejection-free diagnostic after kidney transplantation using blood gene expression. Kidney Int. 2023 Jun;103(6):1167-1179. doi: 10.1016/j.kint.2023.03.019. Epub 2023 Mar 27.

    PMID: 36990211RESULT

  • Ed-Driouch C, Cheneau F, Simon F, Pasquier G, Combes B, Kerbrat A, Le Page E, Limou S, Vince N, Laplaud DA, Mars F, Dumas C, Edan G, Gourraud PA. Multiple sclerosis clinical decision support system based on projection to reference datasets. Ann Clin Transl Neurol. 2022 Dec;9(12):1863-1873. doi: 10.1002/acn3.51649. Epub 2022 Nov 22.

    PMID: 36412095RESULT

  • Girardin FR, Nicolet A, Bestard O, Lefaucheur C, Budde K, Halleck F, Brouard S, Giral M, Gourraud PA, Horcholle B, Villard J, Marti J, Loupy A. Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN). Front Pharmacol. 2023 Apr 27;14:1040584. doi: 10.3389/fphar.2023.1040584. eCollection 2023.

    PMID: 37180729RESULT

  • Girardin FR, Cohen K, Schwenkglenks M, Durand-Zaleski I. Editorial: Pharmacoeconomics in the era of health technology assessment and outcomes research to prioritize resource use, innovation and investment. Front Pharmacol. 2023 May 16;14:1210002. doi: 10.3389/fphar.2023.1210002. eCollection 2023. No abstract available.

    PMID: 37261286RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, kidney biopsy samples for these analysis : Transcriptomics analysis Characteristics of anti HLA DSA analysis on endothelial targets Non-HLA antibodies analysis Omics blood analysis T and B cell analyses (ELISPOT) Blood mRNA

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Kidney TransplantationGene Expression ProfilingRNA, Messenger

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical ProceduresGenetic TechniquesInvestigative TechniquesRNANucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

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

July 16, 2018

First Posted

August 29, 2018

Study Start

November 27, 2018

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

DE(2)FR(4)ES(2)CH(1)