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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
The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP 120 µg/day or 240 µg/day) in Japanese patients with CRF (Primary glomerula...
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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
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...