Impaired graft survival of right kidneys from expanded criteria donors
| ISRCTN | ISRCTN16034394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16034394 |
| Secondary identifying numbers | 121255 |
- Submission date
- 18/07/2024
- Registration date
- 19/07/2024
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Transplantation of right kidneys is more challenging compared to left kidneys. Therefore, the aim of the study is to examine the effect of the donor side on the short- and long-term outcomes after primary kidney transplantation (KT).
Who can participate?
Patients aged 18 years and older who underwent initial living or deceased donor KT at the University Hospital of Leipzig between October 1995 and December 2015
What does the study involve?
The clinicopathological characteristics (signs, symptoms and results of lab tests), outcomes, and survival rates of the patients receiving primary KT were analyzed.
What are the possible benefits and risks of participating?
No patients underwent any new treatments or were exposed to any risks. The KT procedure and postoperative therapy (such as immunosuppression) were not modified for this study.
Where is the study run from?
University Hospital of Leipzig (Germany)
When is the study starting and how long is it expected to run for?
January 1995 to March 2024
Who is funding the study?
University Hospital of Leipzig (Germany)
Who is the main contact?
PD Dr Uwe Scheuermann, uwe.scheuermann@medizin.uni-leipzig.de
Contact information
Public, Scientific, Principal Investigator
Liebigstrasse 20
Leipzig
04103
Germany
 ORCID ID |
0000-0003-0859-9719 |
|---|---|
| Phone | +49 (0)341/ 97-17200 |
| uwe.scheuermann@medizin.uni-leipzig.de |
Study information
| Study design | Single-center retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Outcome and survival of right kidneys |
| Study objectives | Transplantation of right kidneys is more challenging compared to left kidneys. |
| Ethics approval(s) |
Approved 19/04/2016, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig (Liebigstraße 18, Leipzig, 04103, Germany; +49 (0)341 97 15490; ethik@medizin.uni-leipzig.de), ref: 111-16-14032016 |
| Health condition(s) or problem(s) studied | Primary kidney transplantation |
| Intervention | Retrospective analysis of clinicopathological characteristics, outcomes, and survival rates of patients undergoing primary kidney transplantation between 1995 and 2015. Standard statistical tests, including Student’s t-test, chi-squared test, analysis of variance (ANOVA), Kruskal–Wallis test, and Wilcoxon–Mann–Whitney test were used. Univariate and multivariate regression analyses were used to evaluate the risk factors of transplant outcome and survival. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Graft survival up to 10 years after kidney transplantation. Reasons and timepoint of graft loss are analysed. Graft failure was defined as a return to dialysis or preemptive re-transplantation. |
| Secondary outcome measures | 1. Postoperative surgical complications (bleeding, vascular thrombosis, urine leak, wound infection, lymphoceles) up to 90 days after kidney transplantation 2. Renal function is measured using serum creatinine levels at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months after kidney transplantation 3. Patient survival rates up to 10 years after kidney transplantation. Reasons and timepoint of death are analysed. |
| Overall study start date | 01/01/1995 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 604 |
| Key inclusion criteria | Adult patients (≥18 years of age) who underwent initial living or deceased donor kidney transplantation |
| Key exclusion criteria | Multi-organ (combined) transplants or re-transplants |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Germany
Study participating centre
Liebigstrasse 20
Leipzig
04103
Germany
Sponsor information
Hospital/treatment centre
Liebigstrasse 20
Leipzig
04103
Germany
| Phone | +49 (0)341/ 97-17200 |
|---|---|
| chi2@medizin.uni-leipzig.de | |
| Website | http://www.uniklinikum-leipzig.de/ |
"ROR" |
https://ror.org/028hv5492 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Leipzig University
- Location
- Germany
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The study database contains highly sensitive data which may provide insight into clinical and personal information about the patients and lead to the identification of these patients. Therefore, according to organizational restrictions and regulations these data cannot be made publicly available. Repository: "Nephroton" database University Hospital Leipzig. |
Editorial Notes
09/04/2025: The intention to publish date was changed from 01/08/2024 to 01/08/2025.
18/07/2024: Study's existence confirmed by Ethikkommission an der Medizinischen Fakultät der Universität Leipzig.
