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NCT03430414 Clinical Trial

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

Antibody-mediated Rejection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03430414
Other study ID # BASEC-Nr. 2017-02130
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 5, 2018
Last updated February 5, 2018
Start date February 15, 2018
Est. completion date April 30, 2018

Study information
Verified date February 2018
Source University of Zurich
Contact Thomas F. Mueller, Prof.
Phone 044 255 27 75
Email thomas.mueller@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date April 30, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Transcriptome Analysis
Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Thomas Mueller

Outcome
Type Measure Description Time frame Safety issue
Primary Transcriptome mRNA 02.15.2018-03.01.2018
See also
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Active, not recruiting NCT03994783 - Transplant Antibody-Mediated Rejection: Guiding Effective Treatments Phase 3
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Recruiting NCT04368962 - DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients
Completed NCT03444103 - A Pilot Trial of Clazakizumab in Late ABMR Phase 2