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

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).

Completed

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Nephrosclerosis Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beraprost

Drug

Placebo

Drug

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)

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Collaborators

Astellas Pharma Inc

Registry information

Important dates

Study start: 2005
Primary completion: 2008
First posted: Jun 24, 2015
Registry last updated: Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed