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SAR407899A

Phase 1

Chronic Kidney Disease | Small molecule | Nephrology |Sanofi|Last Updated: Aug 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

SAR407899A · 1 trial · 1 indication

Phase 1 1
NCT01485900Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I TreatmentChronic Kidney Disease
COMPLETED20 Analytics
PHASE1COMPLETED
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Chronic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients reporting Adverse Events (AEs)
8 weeks

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALDose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo
Cohort 2EXPERIMENTALDose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo

Interventions

NameTypeDescription
SAR407899ADRUGPharmaceutical form:capsule Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 ...

Countries:MoldovaRomania
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Frequently asked questions about SAR407899A

What is SAR407899A used for?

SAR407899A is an investigational small molecule being developed by Sanofi for the treatment of Chronic Kidney Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under study to assess its safety and tolerability in patients.

Who is developing SAR407899A?

SAR407899A is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is in Phase 1 clinical development for Chronic Kidney Disease, with a completed clinical trial evaluating its safety and tolerability.

What phase is SAR407899A in?

SAR407899A is in Phase 1 clinical development. It is an investigational drug for Chronic Kidney Disease and has not yet received regulatory approval. A Phase 1 clinical trial has been completed to assess the safety and tolerability of repeated dosing in patients with stage 3 chronic kidney disease.

What clinical trials is SAR407899A in?

SAR407899A has one completed clinical trial registered under NCT01485900. This Phase 1 study evaluated repeated dosing to assess safety and tolerability in patients with Chronic Kidney Disease stage 3 who were on stable ACE inhibitor treatment. The trial enrolled 20 participants in Moldova and Romania.

Is SAR407899A FDA approved?

SAR407899A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Chronic Kidney Disease. The drug has completed a Phase 1 trial, but it remains under study and has not been authorized for commercial use by regulatory agencies.

What is the mechanism of action of SAR407899A?

SAR407899A is a small molecule being studied for Chronic Kidney Disease. Its specific molecular target has not been disclosed in available clinical trial information. The drug is in Phase 1 development, with a completed study focused on safety and tolerability in patients with chronic kidney disease.