Reata and Abbott Halt Phase 3 BEACON Trial For Bardoxolone Methyl Amid Serious Safety Concerns

By GabbyPA Latest Reply 2012-11-08 01:48:58 -0600
Started 2012-11-04 05:48:33 -0600

By diaTribe: New, Now, Next

On October 18, Reata and Abbott stopped their phase 3, 2,000-patient BEACON trial for the drug bardoxolone methyl, the most promising candidate in development for the treatment of chronic kidney disease (CKD). The trial was terminated due to an excessive number of serious adverse effects, including death, among those taking bardoxolone in the study. This is shocking and deeply disappointing news, particularly because the earlier phase 2 results for bardoxolone had been so encouraging – the drug showed the potential to both ease the symptoms of CKD and to actually reverse it through anti-inflammatory mechanisms.

The stakes were very high for bardoxolone since nothing of its kind is currently available, and it would have offered a sorely needed treatment for a very ill group of patients. As context for how grave a condition stage 4 CKD is (the disease state being tested in this trial), a 2004 study found that the five-year mortality rate of patients with stage 4 CKD was 46% – worse than many cancers.
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6 replies

doggier 2012-11-05 22:46:41 -0600 Report

the one think that I am afraid of in my future is kidney disease. can someone tell me how i can try to avoid this and keep my kidneys health?

GabbyPA 2012-11-07 11:23:24 -0600 Report

Keeping your sugar in good control is the first line of defense. Eating healthy also helps and I am not sure about the food restrictions to keep damaged ones going. I know proteins are hard for damaged kidneys to deal with, but I am not clear on if a high protein diet will actually harm them.

jayabee52 2012-11-05 02:25:06 -0600 Report

I hadn't been aware of those trials.

I am currently in stage 4 CKD and ALMOST on dialysis. Too bad it went arwy, but good they stopped it before it was released for general use for those with stage 4.

I'd just love to find something which would pull me back from the edge of dialysis.


Nick1962 2012-11-04 17:04:10 -0600 Report

As James commeneted in another thread, this is one of the fears that looms for new trials for diabetic research as well. Rushing to market because we are so demanding of quicker results. I can only hope that some valuable lessons were learned here.

GabbyPA 2012-11-04 05:49:50 -0600 Report

This article is so sad. I hope that they keep working on it. I hope they will try it on patients who have a less sever case of CKD, maybe they will make it.