| Trial ID: | L0539 |
| Source ID: | NCT01588756
|
| Associated Drug: |
Acsdkp-Nh2 Inuline
|
| 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
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy|Chronic Kidney Disease
|
| Interventions: |
DRUG: AcSDKP-NH2 inuline|DRUG: AcSDKP-NH2 Cr-EDTA
|
| Outcome Measures: |
Primary: 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., between day 7 and day 21 | Secondary: safety, all adverse events (clinical or biological adverse events), One month extended to 3 months safety follow up
|
| Sponsor/Collaborators: |
Sponsor: Assistance Publique - Hôpitaux de Paris
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2010-10
|
| Completion Date: |
2015-05
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-01
|
| Locations: |
Clinical Investigation Center, European George Pompidou Hospital, Paris, 75015, France
|
| URL: |
https://clinicaltrials.gov/show/NCT01588756
|
