Kidney Diseases Clinical Trial
— MultiGFROfficial title:
MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate
Verified date | May 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 166 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Patients : Inclusion Criteria: - males or females without pregnancy - age : 18-75 - stable chronic kidney disease stages 1 to 4 (MDRD KDIGO 2005), estimated GFR > 15 mL/min/1.73m² - clinical GFR measurement indication Exclusion Criteria: - kidney transplantation - allergic - acute disease leading to acute change in GFR - heavy metals poisoning (treated or not) - gadolinium contrast agent in the previous month Healthy volunteers : Inclusion criteria - males, 18-35 years old - weight : 60-100 kg , BMI 18-27 kg/m² - estimated GFR > 90 mL/min/1.73 m² (MDRD) - acute diseases in the previous 7 days Exclusion criteria : - uro-nephrological disease (past or present) - nephrotoxic drug chronic use in the previous 2 months - allergic - systemic disease (acute or chronic) |
Country | Name | City | State |
---|---|---|---|
France | Hopital Europeen Georges Pompidou (centre d'investigations cliniques) | Paris | |
France | Hopital Europeen Georges Pompidou (Service de Nephrologie) | Paris | |
France | Hopital Europeen Georges Pompidou (service de Physiologie et des Radioisotopes) | Paris | |
France | CHU Rangueil (service explorations fonctionnelles physiologiques) | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement | Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose. | 1 day | |
Secondary | Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement in each CKD stage | Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose. | 1 day | |
Secondary | Calcium EDTA and Gd-DOTA clearance reproducibility for GFR measurement | Calcium EDTA or Gd-DOTA clearance is measured twice at day 1 and day 15 in healthy volunteers (n= 25) and in CKD patients (n= 25, stages 1 to 4, 5 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose. | 15 days | |
Secondary | Calcium EDTA and Gd-DOTA clearance with single injection for GFR measurement | Calcium EDTA or Gd-DOTA clearance is measured twice at day 1 and day 15 in healthy volunteers (n= 25) and in CKD patients (n= 25, stages 1 to 4, 5 patients for each stage) at equilibrium at day 1 by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose and at day 15 with a single loading dose of Calcium EDTA or Gd-DOTA | 15 days | |
Secondary | Volumes of distribution of Calcium EDTA and Gd-DOTA | Calcium EDTA or Gd-DOTA apparent volumes of distribution are compared to inuline apparent volume of distribution in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage). | 1 day | |
Secondary | Number of participants with adverse events as a measure of safety. | Each event following Calcium EDTA or Gd-DOTA infusion will be listed in healthy volunteers (n = 50) and in patients (n = 300). | 45 days |
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