Chronic Kidney Disease

While acknowledging the “substantial evidence” presented by Ardelyx Inc. in its new drug application for tenapanor, the FDA said in a letter to the pharmaceutical company that the phosphorus control drug lacked “clinical significance.”

For patients with chronic kidney disease, lower values of the hormone serum irisin were associated with a greater likelihood of experiencing cardiovascular events during a follow-up of 3 years, study results showed.

The FDA issued a complete response letter to FibroGen indicating it cannot approve the company’s new drug application that seeks approval of roxadustat for anemia of chronic kidney disease.

An analysis of DAPA-CKD data showed dapagliflozin reduces the risk for kidney failure and mortality in patients with advanced chronic kidney disease, a subgroup that made up 14% of the study population included in the initial trial.

Applying different assessment measures impacted the results of two studies on the progression of chronic kidney disease in children. Alternate evaluation produced variability that altered the CKD conclusions, according to research.

For patients with cancer, the use of immune checkpoint inhibitors was associated with rapid eGFR decline and the subsequent development of chronic kidney disease 1 year after therapy initiation, study findings showed.

In 1989, the FDA’s approval of Epogen – epoetin alfa manufactured by Amgen Inc. – offered patients with kidney disease an opportunity to break away from blood transfusions, the washout after dialysis and improve their quality of life.

In April, the FDA approved use of dapagliflozin (Farxiga, AstraZeneca)to reduce the risk for kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease.

The SGLT2 inhibitor ertugliflozin shows promise for preserving kidney function in patients with type 2 diabetes and atherosclerotic cardiovascular disease, results of a placebo-controlled trial suggested.

Findings from a retrospective cohort study demonstrated a significant association between lower self-rated health and limitations to performing various activities of daily living.