Validation of Serum Creatinine Dosage and Renal Clearance

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323128
First received: May 8, 2006
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Kidney Failure
Procedure: Calculation of inuline clearance
Procedure: Measuring serum creatinine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of Serum Creatinine Dosage and Renal Clearance

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Glomerular filtration ratio [ Time Frame: At time T0 ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: At time T0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2006
Study Completion Date: December 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Calculation of inuline clearance
    Calculation of inuline clearance.
    Procedure: Measuring serum creatinine
    Measuring serum creatinine.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Arjan Van Der Tol, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00323128     History of Changes
Other Study ID Numbers: 2006/037
Study First Received: May 8, 2006
Last Updated: June 1, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014