Validation of Serum Creatinine Dosage and Renal Clearance
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323128
First received: May 8, 2006
Last updated: June 1, 2011
Last verified: June 2011
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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 |
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:
Detailed Description:
-
Procedure: Calculation of inuline clearance
Calculation of inuline clearance.
Procedure: Measuring serum creatinine
Measuring serum creatinine.
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
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: Directorate general for the protection of Public health: Medicines |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013