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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Angiotensin-Converting Enzyme Inhibitors

Criteria

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.