To Assess the Effect of Moderate RI on the PK of CSL112
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled, Pharmacokinetic, Safety, and Tolerability Study of CSL112 in Adult Subjects with Moderate Renal Impairment and in Healthy Adult Subjects with Normal Renal Function
IRAS ID
165716
Contact name
Tim Mant
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2014-005520-10
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Acute coronary syndrome is a life-threatening condition. It refers to a group of conditions (angina, heart attack) in which there is a decreased blood flow in the heart blood vessels (coronary arteries) resulting in the inability of the heart muscle to function properly or causing damage to the heart muscle. The reduced blood flow is due to atherosclerosis. Atherosclerosis causes narrowing of the coronary arteries due to thickening of the blood vessel walls. Atherosclerosis is promoted by Low-Density Lipoproteins called LDL (proteins that carry cholesterol and triglycerides in the blood and deposit them in the blood vessels walls), while High-Density Lipoprotein (HDL) has the opposite function of helping cleaning the vessels. HDL is believed to reverse cholesterol transport and to remove excess cholesterol from arteries back to the liver to be eliminated.
In Acute coronary syndrome (ACS) there is a risk of recurrence of cardiovascular events and death. ACS-related death is more frequent if renal function is poorer. As the number of ACS patients with poor renal function is relatively high, the identification of therapies that are safe and effective in these patients would represent an important advancement in medical therapy.
CSL112 resembles HDL; therefore its use should help reduce the risk of ACS.
The purpose of the study is assess the way the body handles (absorbs, distributes, breaks down and eliminates) a single dose of CL112/ dummy drug (placebo) in patients with clinically established moderate renal impairment and healthy volunteers. During this study patients and volunteers will receive a single dose of CSL112 or placebo as an infusion in a suitable vein.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0025
Date of REC Opinion
20 Feb 2015
REC opinion
Further Information Favourable Opinion