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

Healthy Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588756
• Other study ID #: AOM08193
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 2, 2012
• Last updated: February 27, 2017
• Start date: October 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Healthy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• AcSDKP-NH2 inuline
Once intravenous administration of 100 µg or less
• AcSDKP-NH2 Cr-EDTA
Once intravenous administration of 100 µg or less

Locations

Country	Name	City	State
France	Clinical Investigation Center, European George Pompidou Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glomerular filtration rate	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.	between day 7 and day 21
Secondary	safety	all adverse events (clinical or biological adverse events)	One month extended to 3 months safety follow up