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

Phase 2

Completed

• Conditions: Chronic Renal Failure; Glomerular Disease; Nephrosclerosis
• Interventions: Drug: Placebo; Drug: TRK-100STP high dose; Drug: TRK-100STP low dose

• Registration Number: NCT01090037
• Lead Sponsor: Toray Industries, Inc

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-19
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 892

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRK-100STP	TRK-100STP low dose	-
Placebo	Placebo	-
TRK-100STP	TRK-100STP high dose	-

Primary Outcome Measures

Name	Time	Method
Renal composite endpoints [Time to first occurrence of one of the following events:]	2-4 year	(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