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

NCT ID: NCT03430414

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibody-mediated Rejection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapy Responders

Transcriptome Analysis

Intervention Type DIAGNOSTIC_TEST

Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Non-Responders

Transcriptome Analysis

Intervention Type DIAGNOSTIC_TEST

Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcriptome Analysis

Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas Mueller

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Mueller

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas F. Mueller, Prof.

Role: CONTACT

044 255 27 75 ext. 0041

Onur Sazpinar

Role: CONTACT

078 735 92 00 ext. 0041

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35573002 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BASEC-Nr. 2017-02130

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.