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CompletedNCT01090037Updated Feb 4, 2015

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

A Phase 2/3 interventional study of TRK-100STP high dose and TRK-100STP low dose in Chronic Renal Failure, Glomerular Disease and Nephrosclerosis, sponsored by Toray Industries, Inc. Completed at 7 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-02-04.

Sponsored by Toray Industries, Inc · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
892
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Chronic Renal Failure
  • Glomerular Disease
  • Nephrosclerosis

Keywords

  • ESRD
  • Chronic Renal Failure
  • Prostaglandin
  • Prostacyclin
  • Asian Multinational Study
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 892 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Toray Industries, Inc is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
  • The patient with progressive CRF

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
892 participants (actual)

Study arms

  • Experimental
    TRK-100STP

    Drug: TRK-100STP high dose · Drug: TRK-100STP low dose

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTRK-100STP high dose
  • DrugTRK-100STP low dose
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    (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

    Time frame: 2-4 year

07

Study locations

7 sites
  • Beijing, China
  • Hong Kong, Hong Kong
  • Tokyo, Japan
  • Seoul, Korea, Republic of
  • Kuala Lumpur, Malaysia
  • Taipei, Taiwan
  • Bangkok, Thailand
08

References and documents

Publications

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. PubMed 35224730 ↗
  • Nakamoto H, Fujita T, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design. BMC Nephrol. 2014 Sep 19;15:153. doi: 10.1186/1471-2369-15-153. PubMed 25233856 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01090037
Lead sponsor
Toray Industries, Inc
Collaborators
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Mar 19, 2010
Start date
Mar 2010
Primary completion
Aug 2014
Completion
Jan 2015
Last update
Feb 4, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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