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

Phase 1

Completed

• Conditions: Healthy; Chronic Kidney Disease
• Interventions: Drug: AcSDKP-NH2 inuline; Drug: AcSDKP-NH2 Cr-EDTA

• Registration Number: NCT01588756
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AcSDKP-NH2 inuline	AcSDKP-NH2 inuline	AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less
AcSDKP-NH2 Cr-EDTA	AcSDKP-NH2 Cr-EDTA	AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less

Primary Outcome Measures

Name	Time	Method
glomerular filtration rate	between day 7 and day 21	NAcSDKP clearance for GFR measurement is compared to inuline and 51Cr-EDTA clearance in two phase I studies in 50 healthy subjects. GFR is first assessed at equilibrium by measuring urinary clearances of inuline and NAcSDKP continuously co-infused after a loading dose; and second by plasma clearances of 51Cr-EDTA and NAcSDKP after a single IV bolus. Optimal conditions for using NAcSDKP as a marker for GFR and the tolerability of the peptide are assessed during these studies. Then, a phase IIa study will be performed to compare the 2 methods in 45 patients with various degrees of renal failure.

Secondary Outcome Measures

Name	Time	Method
safety	One month extended to 3 months safety follow up	all adverse events (clinical or biological adverse events)

Trial Locations

Locations (1)

Clinical Investigation Center, European George Pompidou Hospital; 🇫🇷 Paris, France