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

NCT ID: NCT01485900

Last Updated: 2012-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

Brief 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

Detailed Description

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

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

SAR407899A

Intervention Type: DRUG

Pharmaceutical form:capsule

Route of administration: oral

Cohort 2

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

Group Type: EXPERIMENTAL

SAR407899A

Intervention Type: DRUG

Pharmaceutical form:capsule

Route of administration: oral

Interventions

SAR407899A

Pharmaceutical form:capsule

Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 498002

Chisinau, , Moldova

Investigational Site Number 642001

Bucharest, , Romania

Countries

Moldova; Romania

Other Identifiers

2011-003793-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1123-5699

Identifier Type: OTHER

Identifier Source: secondary_id

TDR12446

Identifier Type: -

Identifier Source: org_study_id