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Measurement of MRP2 Function Using Urinary Coproporphyrins (COVOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746044
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : May 15, 2009
Information provided by:
University Hospital, Tours

Brief Summary:
Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be increased in patients with mutations in MRP2/ABCC2 gene.

Condition or disease
Healthy Subjects

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Ratio of Urinary Coproporphyrins I and III as a Potential Biomarker of MRP2 Function in Man
Study Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2009

Healthy volunteers >18y, 20 male, 20 female

Primary Outcome Measures :
  1. Urinary coproporphyrins (I/I+III)ratio [ Time Frame: End of three 24-hours periods ]

Secondary Outcome Measures :
  1. ABCC2 polymorphisms [ Time Frame: At the time of entering in the study ]

Biospecimen Retention:   Samples With DNA
24h urine DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
40 healthy subjects > 18 y 20 male, 20 female

Inclusion Criteria:

  • Healthy
  • > 18 y
  • Affiliated to an health insurance

Exclusion Criteria:

  • Patient not able to understand or to comply to the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746044

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Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
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Study Director: Chantal LE GUELLEC CHRU Tours
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Responsible Party: University Hospital, Tours Identifier: NCT00746044    
Other Study ID Numbers: PHAO07-CLG/COVOL
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009
Keywords provided by University Hospital, Tours: