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

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

SAR407899A

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 498002
Investigational Site Number 642001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients reporting Adverse Events (AEs)

Secondary Outcome Measures

Clinical safety laboratory measurement including hematology and biochemistry

urine and blood renal function markers

ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)

AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)

AUC

Cmax

t1/2z

24-hr ambulatory blood pressure

Full Information

NCT ID

NCT01485900

First Posted

November 24, 2011

Last Updated

August 22, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01485900

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SAR407899A

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Primary Outcome Measure Information:

Title

Number of patients reporting Adverse Events (AEs)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Clinical safety laboratory measurement including hematology and biochemistry

Time Frame

8 weeks

Title

urine and blood renal function markers

Time Frame

8 weeks

Title

ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)

Time Frame

8 weeks

Title

AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)

Time Frame

8 weeks

Title

AUC

Time Frame

8 weeks

Title

Cmax

Time Frame

8 weeks

Title

t1/2z

Time Frame

8 weeks

Title

24-hr ambulatory blood pressure

Time Frame

Day-1, Day 14 and Day 19

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 498002

City

Chisinau

ZIP/Postal Code

2025

Country

Moldova, Republic of

Facility Name

Investigational Site Number 642001

City

Bucuresti

Country

Romania

12. IPD Sharing Statement

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

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