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

T

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

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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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