Back to resultsTRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Beraprost
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Chronic Renal Failure, Prostaglandin, Prostacyclin, Glomerular Disease; Nephrosclerosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1: Exprimental (TRK-100STP)
2: Exprimental (TRK-100STP)
3: Placebo Comparator
Arm Description
high dose
low dose
Placebo
Outcomes
Primary Outcome Measures
Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
Secondary Outcome Measures
Full Information
NCT ID
NCT02480751
First Posted
June 21, 2015
Last Updated
June 26, 2015
Sponsor
Toray Industries, Inc
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT02480751
Brief Title
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc
Collaborators
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Chronic Renal Failure, Prostaglandin, Prostacyclin, Glomerular Disease; Nephrosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Exprimental (TRK-100STP)
Arm Type
Experimental
Arm Description
high dose
Arm Title
2: Exprimental (TRK-100STP)
Arm Type
Experimental
Arm Description
low dose
Arm Title
3: Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Beraprost
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26475266
Citation
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.
Results Reference
derived
Learn more about this trial
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
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