Condition category
Urological and Genital Diseases
Date applied
08/10/2020
Date assigned
16/12/2020
Last edited
16/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.chiesi.de/

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

Publication citations

Additional files

Editorial Notes

13/10/2020: Trial's existence confirmed by the ethics committee of the medical faculty of the Christian-Albrechts-University Kiel.