NCT02480751

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

2.6 years

First QC Date

June 21, 2015

Last Update Submit

June 26, 2015

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic Renal FailureProstaglandinProstacyclinGlomerular Disease; Nephrosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

1: Exprimental (TRK-100STP)

EXPERIMENTAL

high dose

Drug: Beraprost

2: Exprimental (TRK-100STP)

EXPERIMENTAL

low dose

Drug: Beraprost

3: Placebo Comparator

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BeraprostDRUG
1: Exprimental (TRK-100STP)2: Exprimental (TRK-100STP)
PlaceboDRUG
3: Placebo Comparator

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
  • The patient with progressive CRF

You may not qualify if:

  • The patient with secondary glomerular disease
  • The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5.

    PMID: 26475266DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicNephrosclerosis

Interventions

beraprost

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2015

First Posted

June 24, 2015

Study Start

October 1, 2005

Primary Completion

May 1, 2008

Last Updated

June 29, 2015

Record last verified: 2015-06