Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006382

Trial Description

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Title

Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006382
  •   2014/10/01
  •   2012/06/26
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT01630824  (ClinicalTrials.gov)
  •   NTXEdu2012  (University of Jena)
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Health Condition or Problem studied

  •   Chronic Kidney Disease
  •   N17-N19 -  Renal failure
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Interventions/Observational Groups

  •   Other: Structured education program
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
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Primary Outcome

- transplant survival; time frame: 2 years

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/06/30
  •   180
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

- being over 18 years recently had a kidney transplantation able to speak, write and
understand german willing to participate regular visits after kidney transplantation

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Exclusion Criteria

- severe complications after recent kidney transplantation early loss of the kidney
allograft severe allograft dysfunction

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Jena
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    • Novartis
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    •   [---]*
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    • University of Jena
    • Gunter Wolf 
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    • Claudia Schinkoethe 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2015/10/22
* This entry means the parameter is not applicable or has not been set.