Antibody-mediated RejectionNCT03430414
Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy Response
An observational study of Antibody-mediated Rejection, run by Thomas Mueller.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibody-mediated Rejection
- What is being tested?
- Transcriptome Analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2018to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection
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
- Being tested
- Transcriptome Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcriptome AnalysisDiagnostic test
Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies
| Study group | Role | What they receive |
|---|---|---|
| Therapy Responders | Not described Receives: Diagnostic Test: Transcriptome Analysis | |
| Non-Responders | Not described Receives: Diagnostic Test: Transcriptome Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptome
mRNA
Measured: 02.15.2018-03.01.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Feb 2018 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibody-mediated RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Mueller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Mueller, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430414
- Sponsor's protocol ID
- BASEC-Nr. 2017-02130
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35573002
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection
- ClinicalTrials.gov ID
- NCT03430414
- Acronym / sponsor ID
- BASEC-Nr. 2017-02130
- Conditions
- Antibody-mediated Rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas MuellerUniversity, hospital or other
- Study start
- 15 Feb 2018 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy Responders | – | Diagnostic Test: Transcriptome Analysis |
| Non-Responders | – | Diagnostic Test: Transcriptome Analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcriptome AnalysisTranscriptome Analysis of Formalin Fixed Paraffin Embedded biopsies | Diagnostic test | Non-Responders, Therapy Responders |
Primary outcome
Transcriptome
Time frame: 02.15.2018-03.01.2018
mRNA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 35573002Sazpinar 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.
Related trials for Antibody-mediated Rejection
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Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-mediated Rejection, run by Thomas Mueller.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas F. Mueller, Prof. (044 255 27 75 ext. 0041, thomas.mueller@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptome (time frame: 02.15.2018-03.01.2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.