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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Has Stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (using the Cockcroft and Gault equation for calculation of glomerular filtration rate) with proteinuria, including any of the following aetiologies: immunoglobulin A (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.
✓. Is between 18 and 70 years of age, inclusive.
✓. Has a body mass index (BMI) between 18 and 35 kg/m2, inclusive.
✓. Is willing and able to adhere to the protocol requirements.
✓. Provides written informed consent before any study procedure is performed.
Exclusion criteria
✕. Requires peritoneal dialysis or haemodialysis.
✕. Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.
✕
What they're measuring
1
The principal objective of this study is to evaluate whether sitaxsentan reduces proteinuria in people with chronic kidney disease.
. Has a serum albumin in the nephrotic range (\< 30 g/L) during Screening.
✕. Has a sustained sitting systolic blood pressure (BP) \> 160 mmHg or sustained sitting diastolic BP \> 100 mmHg during Screening.
✕. Has postural hypotension during Screening, which is defined as a decrease in systolic BP ≥ 20 mmHg and/or a decrease in diastolic BP ≥ 10 mmHg, comparing sitting and standing measurements.
✕. Has a history and/or evidence of ischaemic heart disease.
✕. Has or had a malignancy, with the exception of adequately-treated basal cell or squamous cell carcinoma of the skin, that required significant medical intervention within the past 3 months and/or is likely to result in death within the next 2 years.
✕. Has a history of allergies or hypersensitivity to sitaxsentan or nifedipine or the excipients of either drug.