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

NCT01090037 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 892

Last updated 2015-02-04

No results posted yet for this study

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

Conditions

  • Chronic Renal Failure
  • Glomerular Disease
  • Nephrosclerosis

Interventions

DRUG

TRK-100STP high dose

DRUG

TRK-100STP low dose

DRUG

Placebo

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Toray Industries, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-08-31
Completion
2015-01-31

Countries

  • China
  • Hong Kong
  • Japan
  • Malaysia
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090037 on ClinicalTrials.gov