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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 FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.

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.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease (ESRD) and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).

Uric acid-lowering therapy might improve kidney outcomes, including kidney failure events, proteinuria, and the rate of change in eGFR, and seem to reduce the risk of cardiovascular events in adults with CKD.

The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.

A recently published report describes the case of a 62-year-old patient who experienced rare but serious central nervous system (CNS) side effects following the initiation of gabapentin therapy.

The FDA has approved a new indication for Invokana (canagliflozin; Janssen) to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and diabetic nephropathy with albuminuria >300mg/day.

The decision to stop the trial was made based on positive efficacy data following a recommendation from the study’s independent DMC.

The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…