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

Primary Purpose

Chronic Renal Failure, Glomerular Disease, Nephrosclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TRK-100STP high dose
TRK-100STP low dose
Placebo
Sponsored by
Toray Industries, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRK-100STP

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Renal composite endpoints [Time to first occurrence of one of the following events:]
(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher

Secondary Outcome Measures

Full Information

First Posted
March 8, 2010
Last Updated
February 3, 2015
Sponsor
Toray Industries, Inc
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01090037
Brief Title
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Official Title
TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)

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
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease: To confirm the superiority of TRK-100STP over placebo To determine the recommended therapeutic dose in the 2 doses of TRK-100STP To assess the safety of TRK-100STP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Glomerular Disease, Nephrosclerosis
Keywords
ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
892 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRK-100STP
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRK-100STP high dose
Intervention Type
Drug
Intervention Name(s)
TRK-100STP low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Renal composite endpoints [Time to first occurrence of one of the following events:]
Description
(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher
Time Frame
2-4 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 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
Facility Information:
City
Beijing
Country
China
City
Hong Kong
Country
Hong Kong
City
Tokyo
Country
Japan
City
Seoul
Country
Korea, Republic of
City
Kuala Lumpur
Country
Malaysia
City
Taipei
Country
Taiwan
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
PubMed Identifier
25233856
Citation
Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design. BMC Nephrol. 2014 Sep 19;15:153. doi: 10.1186/1471-2369-15-153.
Results Reference
derived

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

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