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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00810732

Purpose

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

Condition	Intervention	Phase
Chronic Kidney Disease CRD	Drug: Open Drug: Nifedipine Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Official Title:	The Effects Of Sitaxsentan Once Daily Dosing On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Subjects With Chronic Kidney Disease.

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Nifedipine Sitaxentan

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	27
Study Start Date:	May 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810732

Locations

United Kingdom, SCOTLAND
Pfizer Investigational Site
Edinburgh, SCOTLAND, United Kingdom, EH4 2XU

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1321005, B1321005
Study First Received:	December 17, 2008
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00810732 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.
B1321005

Additional relevant MeSH terms:

Vasodilator Agents
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Physiological Effects of Drugs
Kidney Failure, Chronic
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Nifedipine
Pharmacologic Actions

Membrane Transport Modulators
Urological Manifestations
Signs and Symptoms
Proteinuria
Tocolytic Agents
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010