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

Toray Industries

Status and phase: Completed; Phase 2

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Placebo; Drug: Beraprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT02480751

100CRS01/533-CL-00

Details and patient eligibility

About

The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).

Enrollment: 113 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 3 patient groups, including a placebo group

1: Exprimental (TRK-100STP)

Experimental group

Description:

high dose

Treatment:

Drug: Beraprost

2: Exprimental (TRK-100STP)

Experimental group

Description:

low dose

Treatment:

Drug: Beraprost

3: Placebo Comparator

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo