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

Phase 2

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Placebo; Drug: Beraprost

• Registration Number: NCT02480751
• Lead Sponsor: Toray Industries, Inc

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 Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2008-05
• Status Verified: 2015-06
• Study First Submitted: 2015-06-21
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3: Placebo Comparator	Placebo	Placebo
1: Exprimental (TRK-100STP)	Beraprost	high dose
2: Exprimental (TRK-100STP)	Beraprost	low dose

Primary Outcome Measures

Name	Time	Method
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)