Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Healthy

Treatments: Drug: AcSDKP-NH2 inuline; Drug: AcSDKP-NH2 Cr-EDTA

Study type: Interventional

Funder types: Other

Identifiers

NCT01588756

AOM08193

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

AcSDKP-NH2 inuline

Experimental group

Description:

AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less

Treatment:

Drug: AcSDKP-NH2 inuline

AcSDKP-NH2 Cr-EDTA

Experimental group

Description:

AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less

Treatment:

Drug: AcSDKP-NH2 Cr-EDTA