Chronic Renal Failure Clinical Trial
Official title:
TRK-100STP PhaseIIb/III 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
Status | Completed |
Enrollment | 892 |
Est. completion date | January 2015 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Toray Industries, Inc | Astellas Pharma Inc |
China, Hong Kong, Japan, Korea, Republic of, Malaysia, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | Yes |
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