TRABIO: registry for documenting treatment success after kidney transplant rejections
| ISRCTN | ISRCTN78772632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78772632 |
| Secondary identifying numbers | B 278/16 |
- Submission date
- 08/10/2020
- Registration date
- 16/12/2020
- Last edited
- 25/04/2022
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Nephrology and Hypertension
University Hospital Schleswig-Holstein
Arnold-Heller-Str. 3 Haus C
Kiel
24105
Germany
 ORCID ID |
0000-0002-4492-696X |
|---|---|
| Phone | +49 (0)431 500 23001 |
| friedrich.vonsamson-himmelstjerna@uksh.de |
Study information
| Study design | Observational prospective multicenter cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | An observational, prospective, multi-center cohort study of kidney TRAnsplant BIOpsies (TRABIO) for graft rejections |
| Study acronym | TRABIO |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2015 |
| Completion date | 31/07/2032 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key 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 |
| Key exclusion criteria | 1. Patient participates in an interventional trial 2. Previous known concerns regarding compliance 3. Pregnancy |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- Germany
Study participating centres
Klinik für Innere Medizin IV
Arnold-Heller-Straße 3
Kiel
24105
Germany
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Langenbeckstraße 1
Mainz
55131
Germany
Ernst-Grube-Str. 40
Halle (Saale)
06120
Germany
Kriegsbergstraße 60
Stuttgart
70174
Germany
Abteilung für Nephrologie
Ismaninger Str. 22
München
81675
Germany
Sponsor information
Industry
Gasstraße 6
Hamburg
22671
Germany
| Phone | +49 (0)40 897 24-0 |
|---|---|
| b.makenthun@chiesi.com | |
| Website | https://www.chiesi.de/ |
"ROR" |
https://ror.org/01zrbp537 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/04/2022 | 25/04/2022 | Yes | No |
Editorial Notes
25/04/2022: Publication reference added.
22/03/2021: Internal review.
13/10/2020: Trial's existence confirmed by the ethics committee of the medical faculty of the Christian-Albrechts-University Kiel.
