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

Renal Insufficiency, Chronic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480751
• Other study ID #: 100CRS01/533-CL-00
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2015
• Last updated: June 26, 2015
• Start date: October 2005

Study information

• Verified date: June 2015
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease

• The patient with progressive CRF

Exclusion Criteria:

• The patient with secondary glomerular disease

• The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Nephrosclerosis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Beraprost

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Toray Industries, Inc	Astellas Pharma Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time		50 weeks (Run-in 22weeks, Treatment 28 weeks)	Yes