Kidney Diseases Clinical Trial
Official title:
MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.
Research on estimation and measurement of renal function has been greatly stimulated by the
international concept of chronic kidney disease (CKD) and its classification into stages of
severity based on the level of glomerular filtration rate (GFR) (National Kidney Foundation
KDOQI and ANAES in 2002, KDIGO conference in 2005), and by the development of recommendations
for clinical practice according to this stages. Many efforts have focused on the validation
of new formula to estimate GFR from endogenous markers. Nevertheless, the performance of
these formula is limited by a large inter individual variability, that requires in many cases
the use of GFR measurement using exogenous tracers (extreme anthropometric characteristics,
abnormal production of endogenous tracers, potential kidney donors, dose adjustment,
nephrotoxicity monitoring…). The use of GFR measurement is burdened by a lack of availability
due to methodological, biological and regulatory (for radioactive tracers) constraints.
That's why a need exists for new validated tracers that will be more accessible and easier to
use. Moreover, there are differences between the measurement techniques: single injection of
the tracer or concentration equilibrium obtained by continuous infusion; plasma or urinary
clearance.
Two new tracers for GFR measurement are here offered for validation: Gd-DOTA and
Calcium-EDTA. Gd-DOTA is a macrocyclic paramagnetic contrast product, which can be measured
using an ELISA type immunoassay. Although being widely used in radiology with higher doses
than those that will be used for GFR measurement in the multi-GFR study, Gd-DOTA has never
been involved in systemic nephrogenic fibrosis cases (ProFinest study). Calcium-EDTA has been
used for many years for the chelation of heavy metals. Recently, a colorimetric assay for
Calcium-EDTA measurement has been developed. Gd-DOTA and Calcium-EDTA clearance for GFR
measurement will be compared to inuline clearance in healthy volunteers (25 for each new
tracer) and CKD patients (150 for each new tracer).
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