Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Hemodynamics of Ascending Repeated Oral Doses of SAR407899A in Patients With Moderate Chronic Kidney Disease on Stable Angiotensin Converting Enzyme-inhibitor (ACE-I) Treatment

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.

Inclusion criteria:

• Male and female patients aged between 18 and 79
• Patients with chronic kidney disease (CKD-3)
• Patients should be on stable ACE-I treatment (same type and regimen) for at least 2 months prior to screening
• Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100 kg inclusive if female
• If female, patients must be permanently sterilized for more than 3 months or postmenopausal
• Having given written informed consent prior to the study.

Exclusion criteria:

• Women of child bearing potential.
• Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness
• Active hepatitis, hepatic insufficiency
• Acute renal failure
• Patients requiring dialysis during the study
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• Any history of orthostatic dysregulation (including but not limited to neurocardiogenic syncope, postural orthostatic tachycardia syndrome)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.