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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01090037
Other study ID # 100CRS02/533-CL-003
Secondary ID
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


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
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