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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
Toray Industries, Inc
ClinicalTrials.gov Identifier:
NCT01090037
First received: March 8, 2010
Last updated: May 28, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    (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



Estimated Enrollment: 750
Study Start Date: March 2010
Arms Assigned Interventions
Experimental: TRK-100STP Drug: TRK-100STP high dose Drug: TRK-100STP low dose
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Toray Industries, Inc., Pharmaceutical Clinical Research Dept.
ClinicalTrials.gov Identifier: NCT01090037     History of Changes
Other Study ID Numbers: 100CRS02/533-CL-003
Study First Received: March 8, 2010
Last Updated: May 28, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Hong Kong: Department of Health
China: Food and Drug Administration
Malyasia:Ministry of Health
Thailand:Thai Food and Drug Administration

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Nephrosclerosis
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Beraprost
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013