Study: New Drug Bardoxolone Improves Kidney Function
In Phase II Trial, New Kidney Drug Improved Kidney Function About 30%
New Drug for Kidney Disease: Study Details continued...
Side effects were more common in the drug-treated groups, but most were mild to moderate, the researchers say. Muscle spasms affected 61% in the middle-dose group, but generally went away with time. Other side effects included elevated liver enzymes, nausea, decreased appetite, and low magnesium.
One death occurred in the 75-mg group after the patient had cardiac bypass surgery.
Warnock was an investigator for the phase II study. He is not an investigator for the phase III study, just launched. He is now a consultant for Reata Pharmaceuticals, which supported the phase II study. (Phase II trials focus on effectiveness and provide more safety information. Phase III studies include larger groups and confirm effectiveness, monitor side effects, and collect other information.)
New Drug for Kidney Disease: Perspective
Szczech of the National Kidney Foundation says the results from the current study look impressive but that ''the real safety and efficacy will be found in phase III."
However, she says, based on the way the drug works, it is ''entirely plausible that this will pan out." Part of the reason, she says, is the novel way the medicine works on kidney disease. "This is the first drug that would come at it from the inflammation pathway.''
Patients on dialysis are often financially devastated, she says, even if they have some insurance coverage.
Szczech is also associate professor of medicine at Duke University School of Medicine, Durham, N.C.
She was not involved in the study but has been a consultant for Abbott. Abbott and Reata have a partnership to develop and market the drug outside the U.S. The phase III trial results are expected in 2013.