volunteers with different stage of renal disease or without renal disease
Conditions
Interventions
Product Name: Inutest
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sinistrin
CAS Number: 37311-25-4
Concentration unit: % percent
Concentration type: equal
Concentration number: 25-
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects are adult volunteers participating in the study after an informed consent. Subjects who meet all of the following criteria are eligible for this trial: 1. Aged between 18 and 55 years. 2. Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2. 3. 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. 4. The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months. 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria cannot be selected: 1. Transplant patients 2. Medication that will influence the serumcreatinine. 3. Morbid obesity 4. Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide). 5. History of allergy or hypersensitivity to inulin 6. Donation of blood in the 60 days preceding the first visit. 7. Liver disease, heart failure, nephrotic syndrome. 8. Patients in critically ill conditions. 9. Malnutrition 10. Postrenal kidney failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Validation and standardization of the methodology of serum creatinin measurement in different laboratories and validation of estimated glomerular filtration ratio. ;Secondary Objective: ;Primary end point(s): 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. | — |
Countries
Belgium
Outcome results
None listed