Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

Phase 2

Completed

Brief Summary: This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.

Recruitment & Eligibility

Inclusion Criteria

Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion Criteria

Required 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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for sitaxsentan, orally administered once daily (double blind arm)
Sitaxsentan	Open	Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
Nifedipine	Nifedipine	Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Baseline, Week 6	Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Baseline, Week 3 and 6	The 24-hour ambulatory BP monitoring was performed by using a BP cuff which was attached to the participant's arm, using the same arm throughout the study, with a small monitor that comfortably sits in the pocket of participant. Mean values over 24-hour measurements at each measurement period were calculated. The change in total 24-hour ambulatory monitoring of systemic arterial BP, SBP and DBP at Week 3 and 6 relative to baseline were reported. Baseline was as an average of the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.
Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6	Baseline, Week 3 and 6	Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Baseline was defined as the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.

Locations (2): Clinical Research Centre and Pharmacology Unit
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Edinburgh, Scotland, United Kingdom
the University of Edinburgh, Western General Hospital, Department of Medical Sciences
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Edinburgh, Scotland, United Kingdom

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