Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003971

Trial Description

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Title

German Chronic Kidney Disease Study

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Trial Acronym

GCKD

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URL of the Trial

http://www.gckd.de

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Brief Summary in Lay Language

Chronic kidney disease is an increasing health problem, affecting approximately 10 % of the population. The burden of morbidity and mortality associated with chronic kidney disease derives from progression to end stage renal disease with requirement of dialysis and from a disproportionate risk of cardiovascular diseases including myocardial infarction and stroke.
However, the course of progression of kidney disease and cardiovascular disease in the setting of renal disease is highly variable and factors determining progression and complication rates are to a large extend unknown.

The number of randomized controlled trials in nephrology lags behind all other medical disciplines.
To address these questions the University of Erlangen is coordinating a large prospective observational cohort study in Germany including the cooperation with the universities of Aachen, Berlin, Freiburg, Hannover, Heidelberg, Innsbruck, Jena, München, Regensburg and Würzburg.
The study aims at gaining important insights on the heterogeneity of disease courses in observing a large number of patients over a long period of time, opening ways for a more deliberate and focussed application of existing diagnostic and therapeutic procedures and development of novel and more effective therapies.
The GCKD Study is funded by the KfH Foundation of Preventive Medicine and the Federal Ministry of Education and Research.

Research
Up to 5000 patients with impaired kidney function will be observed over a period of ten years. Observations on the course of the disease, symptoms and complications will be correlated with genetic information and findings from bioanalytical approaches in blood and urine samples applying modern biostatistical methods of data analysis.
The study aims at establishing valid associations between biomarkers affecting the disease progression and opening insights to the question why patients with kidney disease have a tremendously increased risk and disposition of cardiovascular diseases, including elevated blood pressure, myocardial infarction and stroke. Another research focus is placed on the implications and consequences of kidney impairment on general health and quality of life.
These findings on disease course and associated complications will open ways for a more deliberate and focussed application of diagnostic and therapeutic procedures, improve the overall prognosis and help to postpone or avoid onset of dialysis.
GCKD enrols patients with moderate kidney impairment under the care of a specialized nephrologist in Germany.

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Brief Summary in Scientific Language

Chronic kidney disease is an increasing health problem, affecting approximately 10 % of the population. The burden of morbidity and mortality associated with chronic kidney disease derives from progression to end stage renal disease with requirement of dialysis and from a disproportionate risk of cardiovascular diseases including myocardial infarction and stroke.
However, the course of progression of kidney disease and cardiovascular disease in the setting of renal disease is highly variable and factors determining progression and complication rates are to a large extend unknown.

The number of randomized controlled trials in nephrology lags behind all other medical disciplines.
To address these questions the University of Erlangen is coordinating a large prospective observational cohort study in Germany including the cooperation with the universities of Aachen, Berlin, Freiburg, Hannover, Heidelberg, Innsbruck, Jena, München, Regensburg and Würzburg.
The study aims at gaining important insights on the heterogeneity of disease courses in observing a large number of patients over a long period of time, opening ways for a more deliberate and focussed application of existing diagnostic and therapeutic procedures and development of novel and more effective therapies.
The GCKD Study is funded by the KfH Foundation of Preventive Medicine and the Federal Ministry of Education and Research.

Research
Up to 5000 patients with impaired kidney function will be observed over a period of ten years. Observations on the course of the disease, symptoms and complications will be correlated with genetic information and findings from bioanalytical approaches in blood and urine samples applying modern biostatistical methods of data analysis.
The study aims at establishing valid associations between biomarkers affecting the disease progression and opening insights to the question why patients with kidney disease have a tremendously increased risk and disposition of cardiovascular diseases, including elevated blood pressure, myocardial infarction and stroke. Another research focus is placed on the implications and consequences of kidney impairment on general health and quality of life.
These findings on disease course and associated complications will open ways for a more deliberate and focussed application of diagnostic and therapeutic procedures, improve the overall prognosis and help to postpone or avoid onset of dialysis.
GCKD enrols patients with moderate kidney impairment under the care of a specialized nephrologist in Germany.

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Organizational Data

  •   DRKS00003971
  •   2012/05/15
  •   [---]*
  •   yes
  •   Approved
  •   3831, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N19 -  Unspecified renal failure
  •   N00-N08 -  Glomerular diseases
  •   N10-N16 -  Renal tubulo-interstitial diseases
  •   N17-N19 -  Renal failure
  •   N20-N23 -  Urolithiasis
  •   N25-N29 -  Other disorders of kidney and ureter
  •   N30-N39 -  Other diseases of urinary system
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Interventions/Observational Groups

  •   Patients with moderate kidney insufficiency will be interviewed biannually on disease history, disease course, health behavior, quality of Life and complications; a physical exam will be performed and serum, plasma and urine samples will be collected; at the beginning DNA is collected for genetic analyses. There will be no intervention with the therapeutic regime.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

all cause mortality,
myocardial infarction,
end stage renal disease,
halfing of eGFR

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Secondary Outcome

Stroke,
Procedure of revascularisation in PAD,
Hospitalization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/04/01
  •   5000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

eGFR:30-60 ml/min/1,73 m²
OR:
eGFR >60 ml/min/1,73 m²
AND: Proteinuria
(Albuminuria > 300 mg/Tag
OR: total protein > 500 mg/Tag)

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Exclusion Criteria

non caucasian origin, solid organ transplantation, active malignancy within 2 years prior to inclusion, heart insufficiency NYHA IV, unable to provide informed consent

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Addresses

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    • Medizinische Klinik 4 (Nephrologie und Hypertensiologie),
    • Mr.  Prof. Dr.  Kai-Uwe  Eckardt 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 4 (Nephrologie und Hypertensiologie), Universitätsklinikum Erlangen
    • Ms.  Dr.  Stephanie  Titze 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 4 (Nephrologie und Hypertensiologie), Universitätsklinikum Erlangen
    • Ms.  Dr.  Stephanie  Titze 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    • KfH Stiftung Präventivmedizin
    • Martin Behaim Straße 20
    • 63263  Neu Isenburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.