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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 95
Study Start Date: October 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: AcSDKP-NH2 inuline
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
Other Name: AcSDKP-NH2 Cr-EDTA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588756

Contacts
Contact: Anne BLANCHARD, MD, PhD 1 56 09 29 13 ext 33 anne.blanchard@egp.aphp.fr

Locations
France
Clinical Investigation Center, European George Pompidou Hospital Recruiting
Paris, France, 75015
Contact: Anne BLANCHARD, MD, PhD    156092913 ext 33    anne.blanchard@egp.aphp.fr   
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
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01588756     History of Changes
Other Study ID Numbers: AOM08193
Study First Received: April 2, 2012
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

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
Edetic Acid
Goralatide
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2014