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

Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03430414
Enrollment
50
Registered
2018-02-12
Start date
2018-02-15
Completion date
2018-04-30
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated Rejection

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.

Interventions

DIAGNOSTIC_TESTTranscriptome Analysis

Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Sponsors

Thomas Mueller
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Transcriptome02.15.2018-03.01.2018mRNA

Contacts

Primary ContactThomas F. Mueller, Prof.
thomas.mueller@usz.ch044 255 27 75
Backup ContactOnur Sazpinar
onur.sazpinar@uzh.ch078 735 92 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026