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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485900
• Other study ID #: TDR12446
• Secondary ID: 2011-003793-83U1
• Status: Completed
• Phase: Phase 1
• First received: November 24, 2011
• Last updated: August 22, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

The total duration for this study will be around 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• SAR407899A
Pharmaceutical form:capsule Route of administration: oral

Locations

Country	Name	City	State
Moldova, Republic of	Investigational Site Number 498002	Chisinau
Romania	Investigational Site Number 642001	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Moldova, Republic of,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients reporting Adverse Events (AEs)		8 weeks	Yes
Secondary	Clinical safety laboratory measurement including hematology and biochemistry		8 weeks	Yes
Secondary	urine and blood renal function markers		8 weeks	Yes
Secondary	ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)		8 weeks	No
Secondary	AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)		8 weeks	No
Secondary	AUC		8 weeks	No
Secondary	Cmax		8 weeks	No
Secondary	t1/2z		8 weeks	No
Secondary	24-hr ambulatory blood pressure		Day-1, Day 14 and Day 19	Yes