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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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Chronic Renal Failure
TRK-100STP high dose, TRK-100STP low dose, Placebo
Toray Industries, Inc
Published on BioPortfolio: 2014-08-27T03:15:05-0400
The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120
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The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
A treatment schedule in which the total dose of radiation is divided into large doses.
The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.
Nephrology - kidney function
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