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

Toray Industries

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nephrosclerosis; Chronic Renal Failure; Glomerular Disease

Treatments: Drug: Placebo; Drug: TRK-100STP low dose; Drug: TRK-100STP high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090037

100CRS02/533-CL-003

Details and patient eligibility

About

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

Enrollment: 892 patients

Sex: All

Ages: 18 to 75 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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892 participants in 2 patient groups, including a placebo group

TRK-100STP

Experimental group

Treatment:

Drug: TRK-100STP low dose

Drug: TRK-100STP high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo