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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 — DFGBay  

Kidney Disease Clinical Trial

Official title:
Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium, With a Limited Sampling Strategy for the Calculation of Glomerular Filtration Rate (GFR) and Validity Assessment Compared to the Renal Clearance of Inulin : DFGBay

Clinical Trial 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 Rate (GFR). Many formulas exist to assess GFR. However these formulas are unreliable in many clinical situations (old people, obese patients…). Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers. Renal clearance of Inulin is the gold standard. However, using these methods is restricted to specialized services because it is long and expensive.

There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration.

Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (First visit V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation (Second visit V2).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02300376
Study type Interventional
Source University Hospital, Limoges
Contact
Status Completed
Phase Phase 3
Start date December 2014
Completion date December 2017
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