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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480751

Enrollment

113

Registered

2015-06-24

Start date

2005-10-31

Completion date

Unknown

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic Renal Failure, Prostaglandin, Prostacyclin, Glomerular Disease; Nephrosclerosis

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).

Interventions

DRUGBeraprost

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026