Plain English Summary
Background and study aims
Kidney transplantations are whenever possible the treatment of choice in end-stage renal (kidney) disease. However, acute and chronic rejections (when the body recognises the kidney as foreign tissue and attacks it) can limit the long-term outcome of the graft. This registry of TRAnsplant BIOpsies (TRABIO) aims to deepen the understanding of the distinct types of graft rejection and their treatment.
Who can participate?
Adult kidney transplant patients with a medical indication for a kidney biopsy
What does the study involve?
The registry is an observational cohort study, meaning that participation will not change anything about the treatment or diagnostics a patient receives (non-interventional). The results of the kidney biopsy and baseline medical data will be recorded and there will be a short-term follow-up as well as yearly long-term follow-ups for 5 years.
What are the possible benefits and risks of participating?
There are no risks nor individual benefits in participating. Participation will eventually improve the scientific understanding of kidney graft rejections.
Where is the study run from?
University Hospital Schleswig-Holstein (Germany)
When is the study starting and how long is it expected to run for?
November 2015 to July 2032
Who is funding the study?
Chiesi GmbH (Germany)
Who is the main contact?
Dr Friedrich von Samson-Himmelstjerna
friedrich.vonsamson-himmelstjerna@uksh.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Friedrich von Samson-Himmelstjerna
ORCID ID
https://orcid.org/0000-0002-4492-696X
Contact details
Department of Nephrology and Hypertension
University Hospital Schleswig-Holstein
Arnold-Heller-Str. 3 Haus C
Kiel
24105
Germany
+49 (0)431 500 23001
friedrich.vonsamson-himmelstjerna@uksh.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
B 278/16
Study information
Scientific title
An observational, prospective, multi-center cohort study of kidney TRAnsplant BIOpsies (TRABIO) for graft rejections
Acronym
TRABIO
Study hypothesis
In spite of continued efforts, long-term kidney transplantation outcomes remain unsatisfactory. Acute and chronic kidney graft rejections are independent risk factors of graft failure, but evidence for the best treatment strategy is not clear. The TRABIO registry will address these uncertainties by providing data on short-and long-term outcomes after graft rejections.
Ethics approval
Approved 25/07/2016, ethics committee of the medical faculty of the Christian-Albrechts-University Kiel (Arnold-Heller-Str. 3, 24105 Kiel, Germany; no telephone number provided; ethikkomm@email.uni-kiel.de), ref: B 278/16
Study design
Observational prospective multicenter cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Kidney biopsies for suspected acute and chronic rejections in patients with kidney grafts
Intervention
In this observational, prospective cohort study, the researchers intend to enrol 800 kidney transplantation patients undergoing indication kidney biopsy in five transplantation centers across Germany. Baseline data (demography, medical history, immunosuppressive induction and maintenance medication, laboratory results) and detailed histopathology data will be entered into an electronic database upon enrollment. During the first follow-up (within 14 days) and consecutive yearly follow-ups (for up to 5 years), laboratory results, medication and the clinical course will be recorded. Patients will be stratified according to Banff-classification and treatment strategy, and influence on endpoints will be assessed using multivariate regression analysis.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured using patient records annually for 5 years:
1. All-cause mortality
2. Graft survival (defined as the absence of necessity for dialysis)
Secondary outcome measures
Measured using patient records annually for 5 years:
1. Decline in kidney function (≥30% decline of estimated glomerular filtration rate [eGFR] calculated from blood creatinine test, age, body size and gender; or new-onset large proteinuria with >300 mg/dl on urine dipstick)
2. Recurrence of graft rejection
Overall trial start date
01/11/2015
Overall trial end date
31/07/2032
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients that have previously received a living- or deceased-donor kidney transplantation
2. Suspicion of graft rejection with a medical indication for a kidney biopsy
3. Male and female patients 18 years or older
4. Written, informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. Patient participates in an interventional trial
2. Previous known concerns regarding compliance
3. Pregnancy
Recruitment start date
01/09/2016
Recruitment end date
31/07/2026
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinikum Schleswig-Holstein
Campus Kiel
Klinik für Innere Medizin IV
Arnold-Heller-Straße 3
Kiel
24105
Germany
Trial participating centre
Universitätsmedizin Mannheim
V. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Trial participating centre
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Medizinische Klinik und Poliklinik
Langenbeckstraße 1
Mainz
55131
Germany
Trial participating centre
Universitätsklinikum Halle
Universitätsklinik und Poliklinik für Innere Medizin II
Ernst-Grube-Str. 40
Halle (Saale)
06120
Germany
Trial participating centre
Klinikum Stuttgart
Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen
Kriegsbergstraße 60
Stuttgart
70174
Germany
Trial participating centre
Klinikum rechts der Isar
TU München
Abteilung für Nephrologie
Ismaninger Str. 22
München
81675
Germany
Sponsor information
Organisation
Chiesi (Germany)
Sponsor details
Gasstraße 6
Hamburg
22671
Germany
+49 (0)40 897 24-0
b.makenthun@chiesi.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Chiesi Farmaceutici
Alternative name(s)
Chiesi Pharmaceuticals, Chiesi
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Italy
Results and Publications
Publication and dissemination plan
A protocol of the study design will be published (late 2020/at the beginning of 2021). A first publication summarizing the results of the 1-year follow-up data will be published in approximately 2023. Further publications reporting on the longer-term outcomes will follow at a later point.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/07/2031
Participant level data
Other
Basic results (scientific)
Publication list