Validation of Serum Creatinine Dosage and Renal Clearance
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2006
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 2, 2011
June 1, 2011
1.9 years
May 8, 2006
June 1, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Glomerular filtration ratio
At time T0
Serum creatinine
At time T0
Interventions
Calculation of inuline clearance.
Measuring serum creatinine.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Van Holder, MD, PhD
University Hospital, Ghent
- PRINCIPAL INVESTIGATOR
Arjan Van der Tol, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 9, 2006
Study Start
May 1, 2006
Primary Completion
April 1, 2008
Study Completion
December 1, 2010
Last Updated
June 2, 2011
Record last verified: 2011-06