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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

892 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Renal Failure Glomerular Disease Nephrosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TRK-100STP

Group Type EXPERIMENTAL

TRK-100STP high dose

Intervention Type DRUG

TRK-100STP low dose

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TRK-100STP high dose

Intervention Type DRUG

TRK-100STP low dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No