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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01588756
First received: April 2, 2012
Last updated: September 17, 2013
Last verified: December 2011

April 2, 2012
September 17, 2013
October 2010
November 2013   (final data collection date for primary outcome measure)
glomerular filtration rate [ Time Frame: between day 7 and day 21 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01588756 on ClinicalTrials.gov Archive Site
safety [ Time Frame: One month extended to 3 months safety follow up ] [ Designated as safety issue: Yes ]
all adverse events (clinical or biological adverse events)
Same as current
Not Provided
Not Provided
 
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Healthy
  • Chronic Kidney Disease
  • Drug: AcSDKP-NH2 inuline
    Once intravenous administration of 100 µg or less
    Other Name: AcSDKP-NH2 inuline
  • Drug: AcSDKP-NH2 Cr-EDTA
    Once intravenous administration of 100 µg or less
    Other Name: AcSDKP-NH2 Cr-EDTA
  • Experimental: AcSDKP-NH2 inuline
    AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less
    Intervention: Drug: AcSDKP-NH2 inuline
  • Experimental: AcSDKP-NH2 Cr-EDTA
    AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less
    Intervention: Drug: AcSDKP-NH2 Cr-EDTA
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
95
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact: Anne BLANCHARD, MD, PhD 1 56 09 29 13 ext 33 anne.blanchard@egp.aphp.fr
France
 
NCT01588756
AOM08193
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Michel AZIZI, MD, PhD 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
Assistance Publique - Hôpitaux de Paris
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP