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

Toray Industries, Inc892 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

892

Conditions

Chronic Renal Failure Glomerular Disease Nephrosclerosis

Interventions

TRK-100STP high doseDRUG

TRK-100STP low doseDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 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

Locations (7)

Unnamed facility

Beijing, China

Unnamed facility

Hong Kong, Hong Kong

Unnamed facility

Tokyo, Japan

Unnamed facility

Kuala Lumpur, Malaysia

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Renal composite endpoints [Time to first occurrence of one of the following events:]

(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

Time frame: 2-4 year

Data from ClinicalTrials.gov

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