Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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 (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Calcium; Calcium, Dietary; Edetic Acid; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Pentetic Acid

Criteria

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)