DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017