Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006378

Trial Description

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Title

Regulation of L-Arginine Und Its Derivatives of Asymmetrical and Symmetrical Dimethylarginine and L-NG Monomethylarginine (ADMA/SDMA/L-NMMA) in Acute Kidney Injury and Correlation to Cardiac, Renal and Vascular Function and Mortality

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the study is to determine the association between acute kidney injury and
serum levels symmetrical and asymmetrical dimethylarginine (SDMA/ADMA) and their assumptive
influence on mortality, renal function and on arterial stiffness.

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Brief Summary in Scientific Language

Acute kidney injury (AKI) is a frequent complication with severe implications deteriorating
overall prognosis. Nitric oxide (NO)-signal transduction plays an important role in
mediating renal damage. NO is produced by NO-synthase (NOS) with L-arginine as its
substrate. Endogenous L-Arginine derivatives, asymmetric and symmetric dimethylarginines
(ADMA/SDMA), inhibit NO-production directly (AMDA) by blocking NOS activity or indirectly
(SDMA) by blocking cellular L-Arginine uptake.

It is well known that SDMA and ADMA are markers of renal function (SDMA) and cardiovascular
risk (ADMA/SDMA) in patients with chronic kidney disease (CKD). Moreover, ADMA and SDMA
possibly even trigger cardiovascular risk in patients with CKD. However, there is only
little information about the regulation and the influence of ADMA/SDMA in acute kidney
injury.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006378
  •   2015/04/09
  •   2012/02/02
  •   yes
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Secondary IDs

  •   NCT01552525  (ClinicalTrials.gov)
  •   91/10  (Wuerzburg University Hospital)
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Health Condition or Problem studied

  •   Acute Kidney Injury
  •   N17 -  Acute renal failure
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Difference in serum ADMA level between acute kidney injury and renal recovery; time frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
- Difference in serum SDMA level between acute kidney injury and renal recovery; time frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks

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Secondary Outcome

- Associations between ADMA/SDMA serum level and all cause mortality; time frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks
- Associations between ADMA/SDMA serum level and parameters of arterial stiffness; time frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks; Parameters of arterial stiffness include augmentation index and pulse wave velocity
- Associations between ADMA/SDMA serum level and parameters of renal function; time frame: participants will be followed from the time of recruitment to the end of hospital stay, an expected average of 2 weeks; Parameters of renal function include serum creatinine and estimated Glomerular Filtration Rate (eGFR)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/01/31
  •   300
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- acute kidney injury according to the definition of AKIN (Acute Kidney Injury Network)

- no started renal replacement therapy (e.g. dialysis)

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Exclusion Criteria

- dialysis or continuous venovenous hemofiltration before recruitment

- no recovery from kidney injury according to the definition of AKIN (Acute Kidney
Injury Network)

- palliative care

- life expectancy is severely limited (< six months) due to preexisting malignancy or
other disease

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Addresses

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    • Wuerzburg University Hospital
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    • Division of Nephrology Department of Medicine I University Hospital of Wuerzburg
    • Boris B Betz, Dr 
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    • Boris B Betz, Dr 
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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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31.; 17331245
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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 .
  •   1
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.