Condition category
Urological and Genital Diseases
Date applied
16/04/2014
Date assigned
25/04/2014
Last edited
13/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 work 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 years who will be transferred into adult care from 2014-2016.

What does the study involve?
In phase I, 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 study in which we 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?
The study has stared in April 2014 and will run until March 2017.

Who is funding the study?
The study is funded by the KfH Foundation for Preventive Medicine (KfH Stiftung Präventivmedizin) (Germany).

Who is the main contact?
Prof. Lars Pape
Pape.Lars@mh-hannover.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lars Pape

ORCID ID

Contact details

Hannover Medical School
Carl-Neuberg-Straße 1
30655 Hannover
Hannover
D-30625
Germany
-
Pape.Lars@mh-hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TRANSNephro

Study information

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

Acronym

TRANSNephro

Study hypothesis

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

Ethics review board of Hannover Medical School, 06/04/2014, ref: 6660

Study design

Two-armed randomized prospective controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Variation coefficients for immunosuppressive agent levels, measured at the end of the study (1 year after transition)

Secondary outcome measures

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)
2. Serum creatinine levels
3. Transplant survival
4. Patient survival
5. Acute rejection reactions (presence of donor-specific antibodies and chronic humoral rejection)
6. Transplant loss
7. Death
8. Patient satisfaction
9. Health care utilization
10. Patients’ self-reported quality of life and social integration

All outcomes will be measured at the end of the study (1 year after transition).

Overall trial start date

01/05/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 16-21 years
2. Kidney transplantation in history

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patients severely mentally retarded

Recruitment start date

01/05/2014

Recruitment end date

31/03/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Hannover Medical School
Hannover
D-30625
Germany

Sponsor information

Organisation

Hannover Clinical Trials Center (Germany)

Sponsor details

Carl-Neuberg-Straße 1
Hannover
D-30625
Germany
-
businessdevelopment@clinical-trial-center.de

Sponsor type

University/education

Website

http://www.clinical-trial-center.de/

Funders

Funder type

Research organisation

Funder name

KfH Foundation for Preventive Medicine (KfH Stiftung Präventivmedizin) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25539976

Publication citations

Additional files

Editorial Notes