Validation of Serum Creatinine Dosage and Renal Clearance

Kidney Failure Clinical Trial

Official title:

Validation of Serum Creatinine Dosage and Renal Clearance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323128
• Other study ID #: 2006/037
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2006
• Last updated: June 1, 2011
• Start date: May 2006
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Procedure:
• Calculation of inuline clearance
Calculation of inuline clearance.
• Measuring serum creatinine
Measuring serum creatinine.

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis Aalst	Aalst
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration ratio		At time T0	No
Primary	Serum creatinine		At time T0	No

External Links

•   Website University Hospital Ghent