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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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) |
- 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.
- 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 intraveinous administration of 100 µg or less
|
Drug: AcSDKP-NH2 inuline
Once intraveinous administration of 100 µg or less
Other Name: AcSDKP-NH2 inuline
|
|
Experimental: AcSDKP-NH2 Cr-EDTA
AcSDKP-NH2 Cr-EDTA, Once intraveinous administration of 100 µg or less
|
Drug: AcSDKP-NH2 Cr-EDTA
Once intraveinous 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 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Phase I: 18-35 years male
- Phase I: healthy volunteers
- Phase II: 18-75 years patients (both sex)
- Phase II: with Chronic Kidney Disease
Exclusion Criteria:
- Phase I: Smokers
- Phase I: Allergic
Contacts and Locations| Contact: Anne BLANCHARD, MD, PhD | 1 56 09 29 13 ext 33 | anne.blanchard@egp.aphp.fr |
| 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 | |
| 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: | October 30, 2012 |
| 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 18-75 yrs old with chronic Kidney disease |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Edetic Acid Goralatide Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Growth Inhibitors Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013