| Trial ID: | L0414 |
| Source ID: | NCT01090037
|
| Associated Drug: |
Trk-100stp High Dose
|
| Title: |
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure|Glomerular Disease|Nephrosclerosis
|
| Interventions: |
DRUG: TRK-100STP high dose|DRUG: TRK-100STP low dose|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: Toray Industries, Inc | Collaborators: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
892
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-03
|
| Completion Date: |
2015-01
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-04
|
| Locations: |
Beijing, China|Hong Kong, Hong Kong|Tokyo, Japan|Seoul, Korea, Republic of|Kuala Lumpur, Malaysia|Taipei, Taiwan|Bangkok, Thailand
|
| URL: |
https://clinicaltrials.gov/show/NCT01090037
|
