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

Phase 1

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: SAR407899A

• Registration Number: NCT01485900
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SAR407899A	Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo
Cohort 2	SAR407899A	Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo

Primary Outcome Measures

Name	Time	Method
Number of patients reporting Adverse Events (AEs)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical safety laboratory measurement including hematology and biochemistry	8 weeks
urine and blood renal function markers	8 weeks
ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)	8 weeks
AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)	8 weeks
AUC	8 weeks
Cmax	8 weeks
t1/2z	8 weeks
24-hr ambulatory blood pressure	Day-1, Day 14 and Day 19

Trial Locations

Locations (2)

Investigational Site Number 498002; 🇲🇩 Chisinau, Moldova, Republic of

Investigational Site Number 642001; 🇷🇴 Bucuresti, Romania