Clinical trial NCT01588756: Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)
Official title: Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Chronic Kidney Disease
Keywords: Chronic kidney disease
GFR
Inulin
51Cr-EDTA
ASDKP-NH2
Healthy male 18-35 yrs old, non smokers, non allergic
Or Male/female 18-80 yrs old with chronic Kidney disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

Detailed description: Chronic kidney disease (CKD) is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes (kidney failure, complications of decreased kidney function and cardiovascular disease), and high cost. Some of the adverse outcomes can be prevented or delayed by early detection and treatment. However, CKD is frequently underdiagnosed and undertreated. The glomerular filtration rate (GFR) is considered as the best index of renal function. The clinical action plan promoted by International Guidelines groups refers to GFR values. Despite recent improvements, prediction equations developed in order to estimate GFR elicit a huge lack of accuracy when considering the individual patient, especially in case of early CKD. Rigorous assessment of GFR requires the measurement of urinary or plasma clearance of an ideal exogenous filtration marker which is either non-radioactive (inulin, iothalamate, or iohexol) or radioactive ( 51Cr-EDTA or 99mTc DTPA. Measuring clearance with the use of exogenous markers is difficult to perform in clinical practice because it is expensive and cumbersome and needs specialised laboratories and thus, is underused. There is an unmet need for the development of a new non-radioactive GFR tracer that could combine both the analytical accuracy of radioactive tracers and the simplicity of its measurement. Such a tracer should improve clinical care and follow-up of patients.

Eligibility criteria: Inclusion Criteria:

* Phase I: 18-35 years male
* Phase I: healthy volunteers
* Phase II: 18-80 years patients (both sex)
* Phase II: with Chronic Kidney Disease

Exclusion Criteria:

* Phase I: Smokers
* Phase I: Allergic

Primary outcomes:
measure: glomerular filtration rate
timeFrame: between day 7 and day 21
Secondary outcomes:
measure: safety
timeFrame: One month extended to 3 months safety follow up
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Investigation Center, European George Pompidou Hospital
Study officials:
affiliation: Université Paris-Descartes, Faculté de Médecine; Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Centre d'Investigations Cliniques; INSERM, CIC 9201, F-75015 Paris, France
name: Michel AZIZI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mesmin C, Cholet S, Blanchard A, Chambon Y, Azizi M, Ezan E. Mass spectrometric quantification of AcSDKP-NH2 in human plasma and urine and comparison with an immunoassay. Rapid Commun Mass Spectrom. 2012 Jan 30;26(2):163-72. doi: 10.1002/rcm.5326.