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

Tracking Information

First Received Date ^ICMJE

December 17, 2008

Last Updated Date

May 19, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is the mean 24-hour urine total protein level change from baseline at week 6. [ Time Frame: baseline at week 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00810732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: baseline at week 6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effects Of Sitaxsentan Once Daily Dosing On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Subjects With Chronic Kidney Disease.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Kidney Disease
CRD

Intervention ^ICMJE

Drug: Open
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)

Other Name: Sitaxsentan
Drug: Nifedipine
Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)

Other Name: Nifedipine
Drug: Placebo
Placebo for sitaxsentan, orally administered once daily (double blind arm)

Other Name: Placebo

Study Arms / Comparison Groups

Sitaxsentan: Experimental
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)

Intervention: Drug: Open
Nifedipine: Active Comparator
Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)

Intervention: Drug: Nifedipine
Placebo: Placebo Comparator
Placebo for sitaxsentan, orally administered once daily (double blind arm)

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00810732

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

B1321005, B1321005

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP