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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03430414
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
Thomas Mueller, University of Zurich

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.

Condition or disease Intervention/treatment
Antibody-mediated Rejection Diagnostic Test: Transcriptome Analysis

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection
Estimated Study Start Date : February 15, 2018
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Therapy Responders Diagnostic Test: Transcriptome Analysis
Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Non-Responders Diagnostic Test: Transcriptome Analysis
Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Primary Outcome Measures :
  1. Transcriptome [ Time Frame: 02.15.2018-03.01.2018 ]

Biospecimen Description:
RNA Analysis of Formalin Fixed Paraffin Embedded biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03430414

Contact: Thomas F. Mueller, Prof. 044 255 27 75 ext 0041
Contact: Onur Sazpinar 078 735 92 00 ext 0041

Sponsors and Collaborators
Thomas Mueller

Responsible Party: Thomas Mueller, Professor, University of Zurich Identifier: NCT03430414     History of Changes
Other Study ID Numbers: BASEC-Nr. 2017-02130
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs