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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090037
First Posted: March 19, 2010
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Toray Industries, Inc
  Purpose

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 Nephrosclerosis 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 (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090037


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT01090037     History of Changes
Other Study ID Numbers: 100CRS02/533-CL-003
First Submitted: March 8, 2010
First Posted: March 19, 2010
Last Update Posted: February 4, 2015
Last Verified: February 2015

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

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