NCT02300376

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 Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers.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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 11, 2019

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

October 28, 2014

Last Update Submit

January 10, 2019

Conditions

Kidney Disease

Keywords

GFRBayesian modelplasma clearanceCalcium edetate de sodiumInulin

Outcome Measures

Primary Outcomes (1)

  • To estimate the DFG by the Bayesian model

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

    1 week

Secondary Outcomes (1)

  • Concordance of GFRBay

    1 week

Study Arms (1)

Calcium edetate de sodium versus inulin

EXPERIMENTAL

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

Interventions

Dosage of Calcium edetate de sodiumDRUG

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.

Calcium edetate de sodium versus inulin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Limoges, 87 042, France

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Julien ALLARD, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

November 25, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

January 11, 2019

Record last verified: 2016-06

Locations

FR(1)