Skip to main content
OpenTrials
Completed

NCT Number: NCT00323128

Validation of Serum Creatinine Dosage and Renal Clearance

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Algemeen Stedelijk Ziekenhuis Aalst, Aalst, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calculation of inuline clearance

Procedure

Calculation of inuline clearance.

Measuring serum creatinine

Procedure

Measuring serum creatinine.

Primary outcomes

  1. Glomerular filtration ratio

    Time frame: At time T0

  2. Serum creatinine

    Time frame: At time T0

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
May 9, 2006
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.