Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2) (AcSDKP-NH2)
Primary Purpose
Healthy, Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
AcSDKP-NH2 inuline
AcSDKP-NH2 Cr-EDTA
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy focused on measuring 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
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
Sites / Locations
- Clinical Investigation Center, European George Pompidou Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AcSDKP-NH2 inuline
AcSDKP-NH2 Cr-EDTA
Arm Description
AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less
AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
safety
all adverse events (clinical or biological adverse events)
Full Information
NCT ID
NCT01588756
First Posted
April 2, 2012
Last Updated
February 27, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01588756
Brief 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)
Acronym
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AcSDKP-NH2 inuline
Arm Type
Experimental
Arm Description
AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less
Arm Title
AcSDKP-NH2 Cr-EDTA
Arm Type
Experimental
Arm Description
AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less
Intervention Type
Drug
Intervention Name(s)
AcSDKP-NH2 inuline
Intervention Description
Once intravenous administration of 100 µg or less
Intervention Type
Drug
Intervention Name(s)
AcSDKP-NH2 Cr-EDTA
Intervention Description
Once intravenous administration of 100 µg or less
Primary Outcome Measure Information:
Title
glomerular filtration rate
Description
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.
Time Frame
between day 7 and day 21
Secondary Outcome Measure Information:
Title
safety
Description
all adverse events (clinical or biological adverse events)
Time Frame
One month extended to 3 months safety follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel AZIZI, MD, PhD
Organizational 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Investigation Center, European George Pompidou Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22173804
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.
Results Reference
result
Learn more about this trial
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)
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