Sitaxsentan in Proteinuric Chronic Kidney Disease

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

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

Sponsors & Collaborators

• Encysive Pharmaceuticals

  collaborator INDUSTRY

• University of Edinburgh

  lead OTHER

Principal Investigators

• David Webb, MD DSc FRCP FRSE FMedSci · University of Edinburgh

• Neeraj Dhaun, MBChB · University of Edinburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-14

Primary Completion

2009-07-07

Completion

2009-07-07

Countries

• United Kingdom

Study Locations