Status:
COMPLETED
Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin
Lead Sponsor:
University Hospital, Limoges
Conditions:
Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Diagnosis of patients with renal insufficiency and recommendations for medical treatment of patients who suffer from chronic renal failure are based on the different stages of Glomerular Filtration Ra...
Eligibility Criteria
Inclusion
- Inclusion criteria for V1:
- For transplanted patients : patients from 18 to 80 years, after estimation of their renal function by MDRDs formulas (MDRD = Modification of Diet in Renal Disease) , 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.
- Inclusion criteria for V2: Transplanted patients who have participated 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.
Exclusion
- Hypersensitivity to Calcium edetate de sodium
- Inulin or excipients
- Lead or other heavy metal intoxication
- Volume expansion or dehydration
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02300376
Start Date
December 1 2014
End Date
December 1 2017
Last Update
January 11 2019
Active Locations (1)
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1
University Hospital
Limoges, France, 87 042