Phase 2
Completed N=27
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
Source: ClinicalTrials.gov NCT00810732 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6 — 2.07; 2.07; 1.95; -0.62 Grams per 24 hours — p=0.0040
Summary
This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6 |
2.07; 2.07; 1.95; -0.62; -0.06; 0.01 | 0.0040 sig |
| SECONDARY Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6 |
92.94; 92.98; 93.78; -4.59; -1.20; -2.95 | 0.0087 sig |
| SECONDARY Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6 |
7.97; 7.74; 7.94; -0.19; -0.21; -0.21 | 0.8823 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00810732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.