Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy Response

NCT03430414 | Unknown

• 1 other identifier: BASEC-Nr. 2017-02130
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In adult kidney transplant recipients a therapy-responder and non-responder phenotype by antibody mediated rejection will be precisely defined according to clinical and histological characteristics such as creatinine, proteinuria and Banff-classification. Twenty-five patients will be selected each in the therapy-responder and non-responder group. Their stored Formalin Fixed Paraffin Embedded (FFPE) biopsies will be (re)-classified according to the most recent Banff classification. Using Nanostring Technology the gene transcription of therapy-responders versus non-responders will be analyzed and compared to serological and clinical parameters.

Conditions

Antibody-mediated Rejection

Outcome Measures

Primary Outcomes (1)

• Transcriptome

  mRNA

  02.15.2018-03.01.2018

Study Arms (2)

Therapy Responders

Diagnostic Test: Transcriptome Analysis

Non-Responders

Diagnostic Test: Transcriptome Analysis

Interventions

Transcriptome Analysis DIAGNOSTIC_TEST

Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Non-Responders; Therapy Responders

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 ABMR cases in patients who received a kidney transplant between 01.01.2008 - 31.12.2016 will be pre-screened. As an approximate number of 90 kidney transplantations are performed per year at the University Hospital of Zürich, a total of approximately 810 patients will be available for analysis. Yet, according to the inclusion/exclusion criteria we estimate roughly 50 patients to be finally recruited for analysis. Since we estimate a consent rate of about 50%, we will roughly contact 100 patients. A subset of 25 responders and 25 non-responders according to the clinical course will be identified for further analysis

You may qualify if:

• Kidney transplant patients at the University Hospital of Zurich between 01.01.2008 - 31.12.2016 with histologically suspected or confirmed ABMR
• Written consent for further use of data for research purposes

You may not qualify if:

• Age at transplantation \< 18 years
• Combined organ transplantation (incl. Kidney-Pancreas, Kidney-Liver, Kidney-Heart)
• Incomplete laboratory and/or clinical data
• Recurrence of the initial disease
• Insufficient Biopsy Material for NanoString Analysis
• Documented refusal of further data analysis for research purpose

Sponsors & Collaborators

• Thomas Mueller: lead

Related Publications (1)

• Sazpinar O, Gaspert A, Sidler D, Rechsteiner M, Mueller TF. Histologic and Molecular Patterns in Responders and Non-responders With Chronic-Active Antibody-Mediated Rejection in Kidney Transplants. Front Med (Lausanne). 2022 Apr 29;9:820085. doi: 10.3389/fmed.2022.820085. eCollection 2022.

  PMID: 35573002 DERIVED

Biospecimen

RNA Analysis of Formalin Fixed Paraffin Embedded biopsies

MeSH Terms

Interventions

Transcriptome

Intervention Hierarchy (Ancestors)

Transcription, Genetic; Biochemical Phenomena; Chemical Phenomena; Gene Expression; Genetic Phenomena; Genetic Structures

Central Study Contacts

Thomas F. Mueller, Prof.

CONTACT

044 255 27 75; thomas.mueller@usz.ch

Onur Sazpinar

CONTACT

078 735 92 00; onur.sazpinar@uzh.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: February 15, 2018
• Primary Completion: March 1, 2018
• Study Completion: April 30, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02