Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; CRD
Intervention: Open (Drug); Nifedipine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney
disease.
Clinical Details
Official title: The Effects Of Sitaxsentan Once Daily Dosing On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Subjects With Chronic Kidney Disease.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Primary outcome: The primary efficacy endpoint is the mean 24-hour urine total protein level change from baseline at week 6.
Secondary outcome: The secondary efficacy endpoints include the changes from Baseline to week 6 in total 24-hour ambulatory monitoring of systemic arterial BP, Absolute values of the carotid-femoral PWV.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Edinburgh, SCOTLAND EH4 2XU, United Kingdom; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2007
Ending date: March 2009
Last updated: February 12, 2009
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