Patients with chronic kidney disease (CKD) have higher blood pressures than the general population. They also tend to have protein leaking into the urine (proteinuria). CKD, high blood pressure and proteinuria independently and together increase the risk of developing atherosclerosis (hardening) of the arteries that leads to diseases such as heart attack and stroke. Although there are a number of drugs available that lower blood pressure, these are not always fully effective. Furthermore, there are even fewer drugs that simultaneously lower blood pressure, reduce proteinuria, and slow down kidney damage in CKD. Recent research has shown that drugs like sitaxsentan not only lower blood pressure but also reduce proteinuria and potentially slow down the progression of CKD \[1,2\]. Before sitaxsentan can become freely available to individuals with CKD it is important to look at the effects this drug could have on proteinuria and blood pressure. 1. Goddard J, Johnston NR, Hand MF, et al. Endothelin-A receptor antagonism reduces blood pressure and increases renal blood flow in hypertensive patients with chronic renal failure: a comparison of selective and combined endothelin receptor blockade. Circulation 2004;109:1186-1193. 2. Krum H, Viskoper RJ, Lacourciere Y et al. The effect of an endothelin receptor antagonist, bosentan, on blood pressure in patients with essential hypertension. New Engl J Med 1998;338:784-790.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Sitaxsentan 100mg once daily oral dosing for 6 weeks
Nifedipine 30mg once daily oral dosing for 6 weeks
Placebo tablet once daily oral dosing for 6 weeks
Clinical Research Centre, Western General Hospital
Edinburgh, Scotland, United Kingdom
The principal objective of this study is to evaluate whether sitaxsentan reduces proteinuria in people with chronic kidney disease.
Time frame: 6 Weeks
Secondary objective of this study is to evaluate whether sitaxsentan reduces systemic blood pressure in people with chronic kidney disease.
Time frame: 6 weeks
Secondary objective is to determine whether sitaxsentan improves indices of arterial stiffness in people with chronic kidney disease
Time frame: 6 weeks
Secondary objectives is to determine the safety of sitaxsentan in chronic kidney disease
Time frame: 6 weeks
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