Chronic Renal Failure Clinical Trial
Chronic renal failure is a syndrome that renal function is decreased, and the patient number
is increasing. In addition, patients on dialysis have also increased. Depending on the
chronic renal failure aggravated, the deterioration of life caused by the conduct of
dialysis patients is caused. In addition, a problem in dialysis treatment is ongoing
economic burden surface to increase the life of the patient and family. A solution to this
problem is, or stops the progression of chronic renal failure prior to dialysis, it is
necessary to delay. As a treatment for inhibiting the progression of chronic renal failure
is present, along with diet and blood pressure-lowering drugs or a drug therapy used by
kremezin. However, the effect is not enough, new drug development is required.
HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found
during the search active substance that appear when the inflammation in animals. The
investigators confirmed that the substance is present in the urine of a person during the
study, and later established a link between kidney disease hypotheses. When performing the
test in animal model renal failure, chronic renal Through the non-clinical testing of the
HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity
test and antigen tests) showed that a very low toxicity. When going through the review of
the safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory
safety and tolerability. And pharmacokinetic results from the body's absorption in healthy
subjects had been done well, a linear correlation was observed. Finally, it was confirmed
that the most rapidly excreted into the urine.
This study is a Phase 2a clinical trials performed in patients with chronic renal failure in
3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal
failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure
progression and dose setting, and to determine the safety.
n/a
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