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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; CRD

Intervention: Sitaxsentan (Drug); Nifedipine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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 Investigational Site, Edinburgh, Scotland EH4 2XU, United Kingdom
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Last updated: August 8, 2012

Page last updated: August 23, 2015

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