A Phase 3 interventional study of Dosage of Calcium edetate de sodium in Kidney Disease, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by University Hospital, Limoges · Phase 3, Interventional, and Diagnostic
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 Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers.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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
The designing a Bayesian model of the plasma clearance of Calcium edetate de sodium is compared to the renal clearance of Inulin.
Drug: Dosage of Calcium edetate de sodium
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 (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.
To estimate the DFG by the Bayesian model
the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.
Time frame: 1 week
Concordance of GFRBay
Concordance of the Bayesian model of GFR measured during V1 and during V2 to determine the reliability of the method
Time frame: 1 week
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Limoges