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Trial record 1 of 3 for:    "Nephrosclerosis"
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TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
Toray Industries, Inc Identifier:
First received: March 8, 2010
Last updated: February 3, 2015
Last verified: February 2015

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

Condition Intervention Phase
Chronic Renal Failure
Glomerular Disease
Drug: TRK-100STP high dose
Drug: TRK-100STP low dose
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Resource links provided by NLM:

Further study details as provided by Toray Industries, Inc:

Primary Outcome Measures:
  • Renal composite endpoints [Time to first occurrence of one of the following events:] [ Time Frame: 2-4 year ]

    (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

Enrollment: 892
Study Start Date: March 2010
Study Completion Date: January 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRK-100STP Drug: TRK-100STP high dose Drug: TRK-100STP low dose
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01090037

Beijing, China
Hong Kong
Hong Kong, Hong Kong
Tokyo, Japan
Korea, Republic of
Seoul, Korea, Republic of
Kuala Lumpur, Malaysia
Taipei, Taiwan
Bangkok, Thailand
Sponsors and Collaborators
Toray Industries, Inc
Astellas Pharma Inc
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Toray Industries, Inc Identifier: NCT01090037     History of Changes
Other Study ID Numbers: 100CRS02/533-CL-003
Study First Received: March 8, 2010
Last Updated: February 3, 2015

Keywords provided by Toray Industries, Inc:
Chronic Renal Failure
Asian Multinational Study

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents processed this record on April 26, 2017