| Trial ID: | L0317 |
| Source ID: | NCT01485900
|
| Associated Drug: |
Sar407899a
|
| Title: |
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: SAR407899A
|
| Outcome Measures: |
Primary: Number of patients reporting Adverse Events (AEs), 8 weeks | Secondary: Clinical safety laboratory measurement including hematology and biochemistry, 8 weeks|urine and blood renal function markers, 8 weeks|ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure), 8 weeks|AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro), 8 weeks|AUC, 8 weeks|Cmax, 8 weeks|t1/2z, 8 weeks|24-hr ambulatory blood pressure, Day-1, Day 14 and Day 19
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-11
|
| Completion Date: |
2012-08
|
| Results First Posted: |
|
| Last Update Posted: |
2012-08-23
|
| Locations: |
Investigational Site Number 498002, Chisinau, 2025, Moldova, Republic of|Investigational Site Number 642001, Bucuresti, Romania
|
| URL: |
https://clinicaltrials.gov/show/NCT01485900
|
