Study: New Drug Bardoxolone Improves Kidney Function
Study: New Drug Bardoxolone Improves Kidney Function
In Phase II Trial, New Kidney Drug Improved Kidney Function About 30%
Normal GFR is about 90 to 120 milliliters per minute; below 15 is considered late-stage kidney disease.
At the start of the study, all four groups had similar average GFRs, ranging from about 31 to 33.
At 24 weeks, those on the drug had increases in their kidney function, but no substantial differences occurred in the placebo group. At the 52-week mark, those on the drug still had improvement, but there was no substantial improvement in those on placebo.
The 75 mg dose was deemed best, as it produced on average about a 30% increase in kidney function at 52 weeks, Warnock says. ''The maximal effect was apparent in the first 12 to 20 weeks," he says. After that, it reached a plateau and stabilized.
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.)
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.
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...
Normal GFR is about 90 to 120 milliliters per minute; below 15 is considered late-stage kidney disease.
At the start of the study, all four groups had similar average GFRs, ranging from about 31 to 33.
At 24 weeks, those on the drug had increases in their kidney function, but no substantial differences occurred in the placebo group. At the 52-week mark, those on the drug still had improvement, but there was no substantial improvement in those on placebo.
The 75 mg dose was deemed best, as it produced on average about a 30% increase in kidney function at 52 weeks, Warnock says. ''The maximal effect was apparent in the first 12 to 20 weeks," he says. After that, it reached a plateau and stabilized.
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.
