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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Edinburgh, Scotland, EH4 2XU United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Kidney Disease, CRD
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00810732
Pfizer
Completed
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

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Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
The Effects Of Sitaxsentan Once Daily Dosing On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Subjects With Chronic Kidney Disease.
This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • CRD
  • Drug: Sitaxsentan
    Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
    Other Name: Thelin
  • Drug: Nifedipine
    Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm)
  • Drug: Placebo
    Placebo for sitaxsentan, orally administered once daily (double blind arm)
  • Experimental: Sitaxsentan
    Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
    Intervention: Drug: Sitaxsentan
  • Active Comparator: Nifedipine
    Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)
    Intervention: Drug: Nifedipine
  • Placebo Comparator: Placebo
    Placebo for sitaxsentan, orally administered once daily (double blind arm)
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00810732
B1321005
B1321005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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