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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) (AcSDKP-NH2)

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ClinicalTrials.gov Identifier: NCT01588756
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Chronic Kidney Disease Drug: AcSDKP-NH2 inuline Drug: AcSDKP-NH2 Cr-EDTA Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : October 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AcSDKP-NH2 inuline
AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less
Drug: AcSDKP-NH2 inuline
Once intravenous administration of 100 µg or less

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




Primary Outcome Measures :
  1. glomerular filtration rate [ Time Frame: 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 :
  1. safety [ Time Frame: One month extended to 3 months safety follow up ]
    all adverse events (clinical or biological adverse events)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588756


Locations
France
Clinical Investigation Center, European George Pompidou Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01588756     History of Changes
Other Study ID Numbers: AOM08193
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mechlorethamine
Goralatide
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents