Clinical Trial: TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).

Detailed Summary:
Sponsor: Toray Industries, Inc

Current Primary Outcome: Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time [ Time Frame: 50 weeks (Run-in 22weeks, Treatment 28 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Toray Industries, Inc

Dates:
Date Received: June 21, 2015
Date Started: October 2005
Date Completion:
Last Updated: June 26, 2015
Last Verified: June 2015