Chronic Kidney Disease MedDRA version: 17.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857
Conditions
Interventions
Trade Name: CALCIUM EDETATE DE SODIUM SERB 50 mg/ml, solution injectable I.V.
Pharmaceutical Form: Solution for injection
Trade Name: Inutest 25% ampoules
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital, Limoges
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A- Inclusion criteria for V1: - For transplanted patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas, regardless their nephropathy, regardless the age of the transplantation, with a normal state body hydratation, with a social insurance and who have given their prior consent. - For other patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas, who need a reliable assess of their renal function, with a normal state body hydratation, with a social insurance and who have given their prior consent. B- Inclusion criteria for V2: - Transplanted patients who have participed to V1, with stable clinical conditions, with a stable GFR (less than 30% variation of creatinine clearance by MDRDs formulas) and who have given their prior consent. 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Hypersensitivity to Calcium edetate de sodium, Inulin or excipients, - lead or other heavy metal intoxication, - volume expansion or dehydratation, - acute renal disease, - bladder voiding affections, - coagulation disorders, - poor venous capital, - people in guardianship, - patients already involved in an other research, - women in child bearing age without any method of contraception, - pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to develop a Bayesian model of the plasma clearance of Calcium édétate de sodium (DFGBay) in a population of patients who need an accurate measurement of GFR.;Secondary Objective: Estimate, by the realization of the second calculation of the GFRBay, the reliability of this technique. ;Primary end point(s): Primary end point is the DFGBay: the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.;Timepoint(s) of evaluation of this end point: 90, 120, 180 240, 270, 380, 440 and 500 minutes after T0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are Concordance of GFRBay measured during V1 and during V2 to determine the reliability of the method. ;Timepoint(s) of evaluation of this end point: V1 and V2 | — |
Countries
France
Contacts
Public Contactprincipal investigator
university Hospital, Limoges
Outcome results
None listed