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

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

Official Title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Brief Summary:

In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:

  • To confirm the superiority of TRK-100STP over placebo
  • To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
  • To assess the safety of TRK-100STP

Detailed Summary:
Sponsor: Toray Industries, Inc

Current Primary Outcome: Renal composite endpoints [Time to first occurrence of one of the following events:] [ Time Frame: 2-4 year ]

(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value

(ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher



Original Primary Outcome: Renal composite endpoints [Time to first occurrence of one of the following events:] [ Time Frame: 2-4 year ]

(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value

(ii) ESRD (Occurrence of any of i-iii) i Introduction of dialysis ii Renal transplantation iii Increase in SCr to 6.0 mg/dL or higher



Current Secondary Outcome:

Original Secondary Outcome:

Information By: Toray Industries, Inc

Dates:
Date Received: March 8, 2010
Date Started: March 2010
Date Completion:
Last Updated: February 3, 2015
Last Verified: February 2015