Clinical trial NCT01485900: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of patients reporting Adverse Events (AEs)
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical safety laboratory measurement including hematology and biochemistry
timeFrame: 8 weeks
measure: urine and blood renal function markers
timeFrame: 8 weeks
measure: ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)
timeFrame: 8 weeks
measure: AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)
timeFrame: 8 weeks
measure: AUC
timeFrame: 8 weeks
measure: Cmax
timeFrame: 8 weeks
measure: t1/2z
timeFrame: 8 weeks
measure: 24-hr ambulatory blood pressure
timeFrame: Day-1, Day 14 and Day 19
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Investigational Site Number 498002
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: