Skip to main content
OpenTrials
Completed

NCT Number: NCT01090037

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerular Disease Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Nephrosclerosis Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRK-100STP high dose

Drug

TRK-100STP low dose

Drug

Placebo

Drug

Primary outcomes

  1. Renal composite endpoints [Time to first occurrence of one of the following events:]

    Time frame: 2-4 year

    (i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value

    (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Mar 19, 2010
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.