Publications by authors named "S CALTABIANO"
Clin Pharmacol Drug Dev
May 2022
Article Synopsis
- - Daprodustat is a drug being tested for treating anemia in patients with chronic kidney disease, and this study examined how liver impairment affects its metabolism and safety.
- - Participants with mild and moderate liver issues showed increased levels of daprodustat and its metabolites compared to healthy controls, with a 1.5- to 2.0-fold increase in drug exposure.
- - Despite the higher drug levels in those with liver impairment, there were no significant changes in erythropoietin (EPO) levels, and no serious side effects were reported during the study.
Clin Pharmacol Drug Dev
December 2021
Article Synopsis
- Daprodustat, an oral medication being tested for treating anemia in chronic kidney disease, has undergone a study assessing its absorption, distribution, and excretion after both oral and IV doses in healthy men.
- The study found that about 95% of the radiolabeled substance was recovered by day 5, primarily through feces, indicating it is mostly eliminated via the liver and intestines rather than the kidneys.
- Daprodustat showed moderate oral bioavailability (about 66%) and low tissue distribution, with no serious side effects reported, suggesting it is generally well tolerated.
Clin Pharmacol Drug Dev
November 2020
Article Synopsis
- - Daprodustat is a drug that helps stimulate red blood cell production (erythropoiesis) by mimicking the body's response to low oxygen levels, making it a potential treatment for anemia related to chronic kidney disease (CKD).
- - A study involving 64 healthy Japanese males tested two different tablet strengths of daprodustat to check if they were bioequivalent and how food impacted its absorption in the body.
- - Results showed that the 2-mg and 4-mg daprodustat tablets were bioequivalent, and eating a standard meal did not significantly affect how the drug was processed in the body, with the drug being well tolerated among participants.
Article Synopsis
- Daprodustat, a medication aimed at treating anemia in chronic kidney disease (CKD) patients undergoing hemodialysis, was studied for its effectiveness when given three times a week compared to standard daily doses.
- A total of 103 hemodialysis patients, with hemoglobin levels between 9.0 to 11.5 g/dL, were randomized to receive different doses of daprodustat or a placebo over 29 days.
- The results showed that daprodustat increased hemoglobin levels in a dose-dependent manner, was well tolerated, and established important dosing guidelines for further long-term studies in CKD treatment.
Clin Kidney J
October 2019
Article Synopsis
- Current treatments for anemia in chronic kidney disease (CKD) include iron supplements, blood transfusions, and erythropoietin replacement but have limitations; daprodustat is a new oral medication in Phase 3 trials that may overcome some of these issues.
- The study aimed to evaluate the pharmacokinetics (how the drug behaves in the body) of daprodustat in different groups: those with normal kidney function, CKD patients not on dialysis, and those on hemodialysis (HD) or peritoneal dialysis (PD).
- Results showed similar pharmacokinetic properties for daprodustat across all patient groups, indicating consistent absorption and metabolism, even in those undergoing dialysis. *
