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

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ClinicalTrials.gov Identifier: NCT02480751
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Toray Industries, Inc

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).

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Beraprost Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2005
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: Exprimental (TRK-100STP)
high dose
Drug: Beraprost
Experimental: 2: Exprimental (TRK-100STP)
low dose
Drug: Beraprost
Placebo Comparator: 3: Placebo Comparator
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT02480751     History of Changes
Other Study ID Numbers: 100CRS01/533-CL-00
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Toray Industries, Inc:
Chronic Renal Failure
Prostaglandin
Prostacyclin
Glomerular Disease; Nephrosclerosis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Nephrosclerosis
Kidney Diseases
Urologic Diseases
Beraprost
Platelet Aggregation Inhibitors
Vasodilator Agents