Rationale and design of the TRANSNephro study examining transition of post-kidney transplant adolescents
| ISRCTN | ISRCTN22988897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22988897 |
| Protocol serial number | TRANSNephro |
| Sponsor | Hannover Clinical Trials Center (Germany) |
| Funder | KfH Foundation for Preventive Medicine (KfH Stiftung Präventivmedizin) (Germany) |
- Submission date
- 16/04/2014
- Registration date
- 25/04/2014
- Last edited
- 04/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The transition from pediatric nephrology to adult internist nephrology is not yet being carried out in accordance with uniform structuring. Consequently, there are increased risks of deterioration or loss of transplanted kidneys. The aim of this study is to enable the introduction of a sustainable structured transition of adolescent nephrology patients from pediatric to adult care to improve transplant survival.
Who can participate?
All German pediatric kidney recipients aged 16-21 who will be transferred into adult care from 2014-2016
What does the study involve?
In phase I, the patient transition situation in German nephrology departments is evaluated, including an evaluation of the present situation in the view of physicians, nurses and psycho-social support staff. In phase II, a study is conducted to compare the current unstructured transition (control group) to a structured transition (intervention group).
What are the possible benefits and risks of participating?
The possible benefit is to experience a better transition based on case management. There are no risks.
Where is the study run from?
The study is run from Hannover Medical School and supported by the German Pediatric Nephrology Association.
When is the study starting and how long is it expected to run for?
April 2014 to March 2017
Who is funding the study?
KfH Foundation for Preventive Medicine (KfH Stiftung Präventivmedizin) (Germany)
Who is the main contact?
Prof. Lars Pape
Pape.Lars@mh-hannover.de
Contact information
Scientific
Hannover Medical School
Carl-Neuberg-Straße 1
30655 Hannover
Hannover
D-30625
Germany
| Pape.Lars@mh-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed randomized prospective controlled interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Rationale and design of the TRANSNephro study examining transition of post-kidney transplant adolescents: an analysis of present patient-centered care and multicenter randomized prospective open trial to test a new transition model using case-management and smartphone apps |
| Study acronym | TRANSNephro |
| Study objectives | An introduction of a sustainable structured transition of adolescent nephrology patients from pediatric to adult care including smartphone apps and a case manager improves transplant survival. |
| Ethics approval(s) | Ethics review board of Hannover Medical School, 06/04/2014, ref: 6660 |
| Health condition(s) or problem(s) studied | Kidney transplantation |
| Intervention | In phase I of the study, we are evaluating the patient transition situation in German nephrology departments, including an evaluation of the present situation in the view of physicians, nurses, and psycho-social support staff. In phase II, we will conduct a prospective, randomized study in which we compare current unstructured transition (control group) to structured transition (intervention group). The structured transition approach to be applied integrates the core elements of the Berlin transition program, which has not yet been established in German nephrology departments, in combination with two facilitating smartphone apps. |
| Intervention type | Other |
| Primary outcome measure(s) |
Variation coefficients for immunosuppressive agent levels, measured at the end of the study (1 year after transition) |
| Key secondary outcome measure(s) |
1. Change in pre- and post-transfer estimated glomerular filtration rate (eGFR) (using the Schwartz 2009 formula, modification of diet in renal disease formula, and correction for cystatin-C levels) |
| Completion date | 31/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Age 16-21 years 2. Kidney transplantation in history |
| Key exclusion criteria | Patients severely mentally retarded |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- Germany
Study participating centre
D-30625
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/06/2017 | Yes | No | |
| Results article | 03/04/2025 | 04/04/2025 | Yes | No | |
| Protocol article | protocol | 23/12/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/04/2025: Publication reference added.
14/06/2017: Publication reference added.
