NCT01828372|UnknownDMC
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
1,000
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study includes two study parts in which blood is collected from the patients. Study part A (observational study, already received positive ethics committee vote; Our sign: 12-330): Use of blood samples gathered during routine blood withdrawal Study part B (interventional study in the sense of additional blood samples but without an investigational product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of 20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks. The primary objective of this study is to gain an overview about drug concentrations in plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in patients. Any drug may be tested, however the initial focus is on antiinfective, antineoplastic, and antipsychotic drugs. Many published studies show that there is a profound lack of information on pharmacokinetics and interactions of many commonly used drugs in clinical routine, and that drug concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic range (provided that such ranges are known at all).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2013
Actual (reported)April 10, 2013
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pharmacokinetic Outcome Measures (e.g., Cmax, AUC)
These assessments rely on multiple measurements over time and the Time Frame may include multiple time points describing the interval at which data are collected
within four weeks after administration of drug of interest
Theoretical anyone with taking a drug of interest (see "list of substances and metabolites of interest") can join this trial. But we turn mainly our attention to patient groups who are excluded in modern drug approval studies.
Blood withdrawals by either venous puncture or placement of permanent venous catheter.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Pharmacology, Cologne University Hospital
Cologne, North Rhine-Westphalia, 50937, Germany
Uwe Fuhr, Professor
Department of Pharmacology
First Submitted
March 14, 2013
First Posted
April 10, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Estimated (date passed)Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 10, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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