ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300376
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : November 25, 2014
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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 Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers.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).


Condition or disease Intervention/treatment Phase
Kidney Disease Drug: Dosage of Calcium edetate de sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Calcium edetate de sodium versus inulin
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.




Primary Outcome Measures :
  1. To estimate the DFG by the Bayesian model [ Time Frame: 1 week ]
    the DFG assessed by the Bayesian model of the plasma clearance of Calcium edetate de sodium.


Secondary Outcome Measures :
  1. Concordance of GFRBay [ Time Frame: 1 week ]
    Concordance of the Bayesian model of GFR measured during V1 and during V2 to determine the reliability of the method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300376


Contacts
Contact: Julien ALLARD, MD (+33)5 55 05 80 12 julien.allard@chu-limoges.fr

Locations
France
University Hospital Recruiting
Limoges, France, 87 042
Contact: Julien ALLARD, MD    (+33)5 55 05 80 12    julien.allard@chu-limoges.fr   
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Julien ALLARD, MD University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02300376     History of Changes
Other Study ID Numbers: I13034
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Limoges:
GFR
Bayesian model
plasma clearance
Calcium edetate de sodium
Inulin

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Calcium, Dietary
Edetic Acid
Pentetic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Iron Chelating Agents