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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AcSDKP-NH2 inuline

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

Group Type EXPERIMENTAL

AcSDKP-NH2 inuline

Intervention Type DRUG

Once intravenous administration of 100 µg or less

AcSDKP-NH2 Cr-EDTA

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

Group Type EXPERIMENTAL

AcSDKP-NH2 Cr-EDTA

Intervention Type DRUG

Once intravenous administration of 100 µg or less

Interventions

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AcSDKP-NH2 inuline

Once intravenous administration of 100 µg or less

Intervention Type DRUG

AcSDKP-NH2 Cr-EDTA

Once intravenous administration of 100 µg or less

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel AZIZI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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