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

Chronic Kidney Disease Clinical Trial

— FCRD01  

Official title:

THE EFFECTS OF SITAXSENTAN ONCE DAILY DOSING ON PROTEINURIA, 24-HOUR BLOOD PRESSURE, AND ARTERIAL STIFFNESS IN SUBJECTS WITH CHRONIC KIDNEY DISEASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810732
• Other study ID #: B1321005
• Secondary ID: B13210052006-002
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2007
• Est. completion date: March 6, 2009

Study information

• Verified date: August 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 6, 2009
• Est. primary completion date: March 6, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Open
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
• Nifedipine
Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)
• Placebo
Placebo for sitaxsentan, orally administered once daily (double blind arm)

Locations

Country	Name	City	State
United Kingdom	Clinical Research Centre and Pharmacology Unit	Edinburgh	Scotland
United Kingdom	the University of Edinburgh, Western General Hospital, Department of Medical Sciences	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean 24-Hour Urine Total Protein Level at 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.	Baseline, Week 6
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	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.	Baseline, Week 3 and 6
Secondary	Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at 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.	Baseline, Week 3 and 6

External Links

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