Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects (FCRD01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00810732
First received: December 17, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
CRD
Drug: Sitaxsentan
Drug: Nifedipine
Drug: Placebo
Phase 2

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


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
Experimental: Sitaxsentan
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
Drug: Sitaxsentan
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
Other Name: Thelin
Active Comparator: Nifedipine
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 Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00810732     History of Changes
Other Study ID Numbers: B1321005, B1321005
Study First Received: December 17, 2008
Last Updated: August 8, 2012
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:
Renal Insufficiency, Chronic
Kidney Diseases
Proteinuria
Renal Insufficiency
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014