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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01485900

Enrollment

Registered

2011-12-06

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

DRUGSAR407899A

Pharmaceutical form:capsule Route of administration: oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of patients reporting Adverse Events (AEs)	8 weeks

Secondary

Measure	Time frame
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
Clinical safety laboratory measurement including hematology and biochemistry	8 weeks
Cmax	8 weeks
t1/2z	8 weeks
24-hr ambulatory blood pressure	Day-1, Day 14 and Day 19
AUC	8 weeks

Countries

Moldova, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026