FDA Warns of Potential Chemical Exposure With Certain Hemodialysis Machines
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
Study findings suggest the nephroprotective effects of both drug classes are complementary.
Study findings highlight an “unmet need” for newer therapies.
Colchicine, a plant-derived alkaloid, has a broad range of anti-inflammatory effects that interfere with neutrophil function, according to investigators.
The NDA is supported by data from 5 ASCEND phase 3 clinical trials.
In a study of patients with CKD and/or heart failure on RAASi therapy, the proportion of patients who received dose reductions or had therapy discontinued after new-onset hyperkalemia increased with hyperkalemia severity.
A review of regulatory and drug development status updates.
The NDA submission included data from 36 clinical trials involving over 8000 patients.
Improvement also seen in lipid metabolism, with increase in LDL cholesterol and decrease in HDL cholesterol
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.