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

Toray Industries, Inc113 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

113

Conditions

Renal Insufficiency, Chronic

Interventions

BeraprostDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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