Status:
TERMINATED
Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Renal Insufficiency, Chronic
Kidney Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 (...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Patients :
- 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
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT02286258
Start Date
October 1 2014
End Date
February 1 2017
Last Update
May 18 2018
Active Locations (4)
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1
Hopital Europeen Georges Pompidou (centre d'investigations cliniques)
Paris, France, 75015
2
Hopital Europeen Georges Pompidou (Service de Nephrologie)
Paris, France, 75015
3
Hopital Europeen Georges Pompidou (service de Physiologie et des Radioisotopes)
Paris, France, 75015
4
CHU Rangueil (service explorations fonctionnelles physiologiques)
Toulouse, France, 31059