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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)

Primary Purpose

Kidney Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dosage of Calcium edetate de sodium
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Disease focused on measuring GFR, Bayesian model, plasma clearance, Calcium edetate de sodium, Inulin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcium edetate de sodium versus inulin

Arm Description

The designing a Bayesian model of the plasma clearance of Calcium edetate de sodium is compared to the renal clearance of Inulin.

Outcomes

Primary Outcome Measures

To estimate the DFG by the Bayesian model
the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.

Secondary Outcome Measures

Concordance of GFRBay
Concordance of the Bayesian model of GFR measured during V1 and during V2 to determine the reliability of the method

Full Information

First Posted
October 28, 2014
Last Updated
January 10, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02300376
Brief Title
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
Acronym
DFGBay
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
GFR, Bayesian model, plasma clearance, Calcium edetate de sodium, Inulin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium edetate de sodium versus inulin
Arm Type
Experimental
Arm Description
The designing a Bayesian model of the plasma clearance of Calcium edetate de sodium is compared to the renal clearance of Inulin.
Intervention Type
Drug
Intervention Name(s)
Dosage of Calcium edetate de sodium
Intervention Description
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.
Primary Outcome Measure Information:
Title
To estimate the DFG by the Bayesian model
Description
the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Concordance of GFRBay
Description
Concordance of the Bayesian model of GFR measured during V1 and during V2 to determine the reliability of the method
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien ALLARD, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87 042
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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