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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00323128
Other study ID # 2006/037
Secondary ID
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


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
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