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

Information source: Toray Industries, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Insufficiency, Chronic

Intervention: Beraprost (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Toray Industries, Inc

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).

Clinical Details

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

Primary outcome: Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time

Eligibility

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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 and Contacts

Additional Information

Starting date: October 2005
Last updated: June 26, 2015

Page last updated: August 23, 2015

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