NCT01485900

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

November 24, 2011

Last Update Submit

August 22, 2012

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients reporting Adverse Events (AEs)

    8 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: SAR407899A

Cohort 2

EXPERIMENTAL

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

Drug: SAR407899A

Interventions

SAR407899ADRUG

Pharmaceutical form:capsule Route of administration: oral

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational Site Number 498002

Chisinau, 2025, Moldova

Location

Investigational Site Number 642001

Bucharest, Romania

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2011

First Posted

December 6, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

MO(1)RO(1)