EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
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The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
Despite favorable efficacy data, the HIF-PHI failed to demonstrate noninferiority to the ESA in patients with CKD with respect to the primary MACE safety endpoint.
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Patients on hemodialysis who use opioids concurrently with a short-acting benzodiazepine are especially at risk for early death, a study found.
The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.