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Validation of Serum Creatinine Dosage and Renal Clearance

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.
ClinicalTrials.gov Identifier: NCT00323128
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.

Condition or disease Intervention/treatment Phase
Kidney Failure Procedure: Calculation of inuline clearance Procedure: Measuring serum creatinine Phase 1

Detailed Description:
In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Serum Creatinine Dosage and Renal Clearance
Study Start Date : May 2006
Primary Completion Date : April 2008
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine
U.S. FDA Resources


Intervention Details:
    Procedure: Calculation of inuline clearance
    Calculation of inuline clearance.
    Procedure: Measuring serum creatinine
    Measuring serum creatinine.


Primary Outcome Measures :
  1. Glomerular filtration ratio [ Time Frame: At time T0 ]
  2. Serum creatinine [ Time Frame: At time T0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2.
  • Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
  • The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months.
  • Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples.

Exclusion Criteria:

  • Transplant patients
  • Medication that will influence the serumcreatinine.
  • Morbid obesity
  • Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide).
  • History of allergy or hypersensitivity to inulin
  • Donation of blood in the 60 days preceding the first visit.
  • Liver disease, heart failure, nephrotic syndrome.
  • Patients in critically ill conditions.
  • Malnutrition
  • Postrenal kidney failure

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 ClinicalTrials.gov identifier (NCT number): NCT00323128


Locations
Belgium
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Van Holder, MD, PhD University Hospital, Ghent
Principal Investigator: Arjan Van der Tol, MD University Hospital, Ghent

Additional Information:
Responsible Party: Arjan Van Der Tol, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00323128     History of Changes
Other Study ID Numbers: 2006/037
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases