NCT00817037

Sitaxsentan in Proteinuric Chronic Kidney Disease

The Effect of Sitaxsentan Once Daily Dosing on Proteinuria, 24-hour Systemic Blood Pressure, and Arterial Stiffness in Subjects With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Disease
• Proteinuria
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Sitaxsentan	Sitaxsentan 100mg once daily oral dosing for 6 weeks
DRUG	Nifedipine	Nifedipine 30mg once daily oral dosing for 6 weeks
DRUG	Placebo tablet	Placebo tablet once daily oral dosing for 6 weeks

Timeline

• Start date: 2007-07-14
• Primary completion: 2009-07-07
• Completion: 2009-07-07
• First posted: 2009-01-06
• Last updated: 2025-02-07

Locations

1 site across 1 country: United Kingdom