Primary Objective: * To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease (CKD) on stable angiotensin converting enzyme-inhibitor (ACE-I) Secondary Objectives: * To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate * The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is (AcSDKP) * The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is
The total duration for this study will be around 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Pharmaceutical form:capsule Route of administration: oral
Investigational Site Number 498002
Chisinau, Moldova
Investigational Site Number 642001
Bucharest, Romania
Number of patients reporting Adverse Events (AEs)
Time frame: 8 weeks
Clinical safety laboratory measurement including hematology and biochemistry
Time frame: 8 weeks
urine and blood renal function markers
Time frame: 8 weeks
ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)
Time frame: 8 weeks
AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)
Time frame: 8 weeks
AUC
Time frame: 8 weeks
Cmax
Time frame: 8 weeks
t1/2z
Time frame: 8 weeks
24-hr ambulatory blood pressure
Time frame: Day-1, Day 14 and Day 19
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.