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

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090037
• Other study ID #: 100CRS02/533-CL-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 8, 2010
• Last updated: February 3, 2015
• Start date: March 2010
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of HealthHong Kong: Department of HealthChina: Food and Drug AdministrationMalyasia:Ministry of HealthThailand:Thai Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 892
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Glomerular Disease
• Kidney Failure, Chronic
• Nephrosclerosis
• Renal Insufficiency

Intervention

Drug:
• TRK-100STP high dose

• TRK-100STP low dose

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Toray Industries, Inc	Astellas Pharma Inc

Countries where clinical trial is conducted

China,  Hong Kong,  Japan,  Korea, Republic of,  Malaysia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal composite endpoints [Time to first occurrence of one of the following events:]	(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	2-4 year	Yes