TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Information source: Toray Industries, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Renal Failure; Glomerular Disease; Nephrosclerosis
Intervention: TRK-100STP high dose (Drug); TRK-100STP low dose (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Toray Industries, Inc
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
Clinical Details
Official title: TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Renal composite endpoints [Time to first occurrence of one of the following events:]
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Beijing, China
Hong Kong, Hong Kong
Tokyo, Japan
Seoul, Korea, Republic of
Kuala Lumpur, Malaysia
Taipei, Taiwan
Bangkok, Thailand
Additional Information
Starting date: March 2010
Last updated: February 3, 2015
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