Chronic Renal Failure, Glomerular Disease, Nephrosclerosis
Conditions
Keywords
ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study
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
Interventions
DRUGTRK-100STP high dose
DRUGTRK-100STP low dose
DRUGPlacebo
Sponsors
Astellas Pharma Inc
Toray Industries, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* The patient with secondary glomerular disease * The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal composite endpoints [Time to first occurrence of one of the following events:] | 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 |
Countries
China, Hong Kong, Japan, Malaysia, South Korea, Taiwan, Thailand
Outcome results
None listed