Validation of Serum Creatinine Dosage and Renal Clearance

June 1, 2011 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Kidney Failure

Intervention / Treatment

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

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Aalst, Belgium
    - Algemeen Stedelijk Ziekenhuis Aalst
  - Ghent, Belgium, 9000
    - University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glomerular filtration ratio Time Frame: At time T0	At time T0
Serum creatinine Time Frame: At time T0	At time T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

Principal Investigator: Raymond Van Holder, MD, PhD, University Hospital, Ghent
Principal Investigator: Arjan Van der Tol, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

website University Hospital Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria