Chronic Kidney DiseaseNCT01630824
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
A study testing Structured education program in people with Chronic Kidney Disease, run by University of Jena at 1 site in Germany.
Trial summary
Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Structured education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation
Who cannot join
- severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Nephrology, University of Jena
Jena, Thuringia, 07749
Claudia Schinkoethe, 004936419324623, claudia.schinkoethe@med.uni-jena.de
About this study
Official title: Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.
- Conditions
- Chronic Kidney Disease
- Being tested
- Structured education program
- Keywords
- education program, kidney transplantation, renal transplantation, evaluation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education programOther
structured education program after kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Education | Other | Kidney transplant recipients, who undergo the structured education program Receives: Other: Structured education program |
| Control | No intervention | Kidney transplant recipients without structured education programm |
What is being measured
The primary outcome is the main question the study is designed to answer.
transplant survival
Measured: 2 years
Secondary outcomes (5)
number of rejections
Measured: 2 years
days at hospital
Measured: 2 years
blood pressure control
Measured: 2 years
number of infectious complications
Measured: 2 years
quality of life (QoL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Claudia Schinkoethe, University of Jena
- Investigators
- Gunter Wolf, Principal investigator, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630824
- Sponsor's protocol ID
- NTXEdu2012
- Status last verified
- May 2013
- First submitted
- 26 Jun 2012
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01630824
- Acronym / sponsor ID
- NTXEdu2012
- Conditions
- Chronic Kidney Disease
- Keywords
- education program, kidney transplantation, renal transplantation, evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- 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.
Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Other | Other: Structured education programKidney transplant recipients, who undergo the structured education program |
| Control | No intervention | –Kidney transplant recipients without structured education programm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation
Key exclusion criteria (1 listed)
- severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction
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 |
|---|---|---|
| Structured education programstructured education program after kidney transplantation | Other | Education |
Primary outcome
transplant survival
Time frame: 2 years
5 secondary outcomes
number of rejections
Time frame: 2 years
days at hospital
Time frame: 2 years
blood pressure control
Time frame: 2 years
number of infectious complications
Time frame: 2 years
quality of life (QoL)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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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. This study is not recruiting at the moment.
Gunter Wolf principal investigator
University of Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education program in people with Chronic Kidney Disease, run by University of Jena 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 May 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Schinkoethe (004936419324623, claudia.schinkoethe@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transplant survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2013.