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

NCT01090037 | Completed Phase 2 DMC

• 1 other identifier: 100CRS02/533-CL-003
• Study Type: interventional
• Target: 892
• Locations: 7 countries
• Sites: 7

Brief 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

Conditions

Chronic Renal Failure; Glomerular Disease; Nephrosclerosis

Keywords

ESRD; Chronic Renal Failure; Prostaglandin; Prostacyclin; Asian Multinational Study

Outcome Measures

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

  2-4 year

Study Arms (2)

TRK-100STP

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRK-100STP high dose DRUG

TRK-100STP

TRK-100STP low dose DRUG

TRK-100STP

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The patient with secondary glomerular disease
• The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Sponsors & Collaborators

• Toray Industries, Inc: lead
• Astellas Pharma Inc: collaborator

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Related Publications (2)

• 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.

  PMID: 35224730 DERIVED

• 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.

  PMID: 25233856 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Nephrosclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

TW (1); TH (1); HK (1); MY (1); KR (1); JP (1); CN (1)