Chronic Kidney Disease Requiring Chronic DialysisS&F4NTxNCT06040281
Smart and Fit for Kidney Transplantation
A study testing intensive individual support in nutrition and exercise in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- intensive individual support in nutrition and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be on dialysis
- Patients ≥ 18 years of age
- Patients who own a smartphone
- Patients must be willing to undergo inpatient rehabilitation within the project period
- signed informed consent and data protection regulation
Who cannot join
- Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
- Patients who have already participated in a similar project
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Mario Schiffer, Prof., +4991318539002, mario.schiffer@uk-erlangen.de
About this study
Official title: The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.
Read the detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.
- Being tested
- intensive individual support in nutrition and exercise, Usual Care
- Keywords
- Transplantation, Prehabilitation, Exercise and Nutritional Support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive individual support in nutrition and exerciseBehavioural
Intensive care for nutrition and exercise adapted to the social context. Individualised exercise and nutrition recommendations.
three weeks of inpatient rehabilitation with an individual plan of treatment, which includes medical care, sports therapy, physiotherapy, ergotherapy, nutritional education and psychological care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
Usual CareBehavioural
Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise Receives: Behavioral: intensive individual support in nutrition and exercise |
| Control | Active comparator | usual care App-assisted Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
measured in kg by bio-impedance analysis
Measured: 6 and 12 month
body fat mass
measured in kg by bio-impedance analysis
Measured: 6 and 12 month
Secondary outcomes (7)
Six-Minutes-Walk test (6MWT)
measured in distance (meter)
Measured: 6 and 12 month
Sit-to-stand test (STS60)
measured in number of repetitions in 60 seconds
Measured: 6 and 12 month
Timed-up-and-go test (TUG)
measured in time (seconds)
Measured: 6 and 12 month
Quality of life by Short Form Health Survey (SF-12)
measured in change of scale by questionnaire
Measured: 6 and 12 month
Fried Frailty Scale
measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail)
Measured: 6 and 12 month
One-Legged Stance Test
measured in time (seconds)
Measured: 6 and 12 month
Stair Climb Test
measured in time (seconds)
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start18 Sep 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment in 1:1 ratio to either the intervention group (app-assisted, individual support in nutrition and exercise, three-week comprehensive rehabilitation) or control group (Usual care and app-assisted)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- m&i Fachklinik Bad Heilbrunn, Carealytix Digital Health GmbH
- Responsible party
- Sponsor
- Investigators
- Mario Schiffer, Prof., Study director, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040281
- Sponsor's protocol ID
- GE8-2496-IMV-2019-V2
- Acronym
- S&F4NTx
- Status last verified
- Dec 2024
- First submitted
- 8 Sep 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krusemark H, Kleemann J, Weigand J, Kannenkeril D, Heller K, Hepp T, Albersmeyer M, Gerbig D, Schiffer M. A randomized, controlled, 12-month trial on the effects of an interdisciplinary treatment approach in ESRD patients: study protocol of the smart and fit for kidney transplantation trial (S&F4KTx). Trials. 2025 Aug 21;26(1):298. doi: 10.1186/s13063-025-09022-2.
PubMed 40841967
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06040281
- Acronym / sponsor ID
- S&F4NTx / GE8-2496-IMV-2019-V2
- Keywords
- Transplantation, Prehabilitation, Exercise and Nutritional Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- m&i Fachklinik Bad Heilbrunn, Carealytix Digital Health GmbH
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.
Detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment in 1:1 ratio to either the intervention group (app-assisted, individual support in nutrition and exercise, three-week comprehensive rehabilitation) or control group (Usual care and app-assisted)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: intensive individual support in nutrition and exerciseApp-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise |
| Control | Active comparator | Behavioral: Usual Careusual care App-assisted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be on dialysis
- Patients ≥ 18 years of age
- Patients who own a smartphone
- Patients must be willing to undergo inpatient rehabilitation within the project period
- signed informed consent and data protection regulation
Key exclusion criteria (2 listed)
- Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
- Patients who have already participated in a similar project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive individual support in nutrition and exerciseIntensive care for nutrition and exercise adapted to the social context. Individualised exercise and nutrition recommendations. three weeks of inpatient rehabilitation with an individual plan of treatment, which includes medical care, sports therapy, physiotherapy, ergotherapy, nutritional education and psychological care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) | Behavioural | Intervention |
| Usual CareUsual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) | Behavioural | Control |
Primary outcome
muscle mass
Time frame: 6 and 12 month
measured in kg by bio-impedance analysis
body fat mass
Time frame: 6 and 12 month
measured in kg by bio-impedance analysis
7 secondary outcomes
Six-Minutes-Walk test (6MWT)
Time frame: 6 and 12 month
Sit-to-stand test (STS60)
Time frame: 6 and 12 month
Timed-up-and-go test (TUG)
Time frame: 6 and 12 month
Quality of life by Short Form Health Survey (SF-12)
Time frame: 6 and 12 month
Fried Frailty Scale
Time frame: 6 and 12 month
One-Legged Stance Test
Time frame: 6 and 12 month
Stair Climb Test
Time frame: 6 and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40841967Krusemark H, Kleemann J, Weigand J, Kannenkeril D, Heller K, Hepp T, Albersmeyer M, Gerbig D, Schiffer M. A randomized, controlled, 12-month trial on the effects of an interdisciplinary treatment approach in ESRD patients: study protocol of the smart and fit for kidney transplantation trial (S&F4KTx). Trials. 2025 Aug 21;26(1):298. doi: 10.1186/s13063-025-09022-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Schiffer, Prof. study director
Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive individual support in nutrition and exercise in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helge Krusemark (+4991318542966, helge.krusemark@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass (time frame: 6 and 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.