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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: SAR407899A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485900

2011-003793-83 (EudraCT Number)

TDR12446

U1111-1123-5699 (Other Identifier)

Details and patient eligibility

About

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

Full description

The total duration for this study will be around 8 weeks.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo

Treatment:

Drug: SAR407899A

Cohort 2

Experimental group

Description:

Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo

Treatment:

Drug: SAR407899A