Status:
COMPLETED
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Lead Sponsor:
Sanofi
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 enzym...
Detailed Description
The total duration for this study will be around 8 weeks.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01485900
Start Date
November 1 2011
End Date
August 1 2012
Last Update
August 23 2012
Active Locations (2)
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1
Investigational Site Number 498002
Chisinau, Moldova, 2025
2
Investigational Site Number 642001
Bucharest, Romania