Session: High-Impact Clinical Trials
Presenter: Robert Provenzano, MD, FACP, FASN, Chief Medical Officer, Nephrology Practice Solutions & Vice President, Medical Affairs
Before a packed crowd, Robert Provenzano, MD, FASM, DaVita Healthcare, presented pooled efficacy and cardiovascular (CV) safety analyses from the pivotal Phase III program assessing roxadustat for the treatment of patients with anemia from chronic kidney disease (CKD).
“Here’s what every clinical nephrologist knows: All dialysis patients aren’t created equal. There’s CKD 1, 2, 3, 4, 5. There are different physiological requirements. There’s the non-dialysis dependent CKD pool, dialysis dependent CKD pool, and going deeper, the incident dialysis pool. They’re all different populations. And our studies pool our knowledge on treating anemia in each of them.”
The results, as Dr. Provenzano explained, focus on primary efficacy end points and cardiovascular safety endpoints — with roxadustat demonstrating efficacy in both end points.
While the results represent an important advancement, Dr. Provenzano added that it’s about time. “We’ve been treating anemia for 25 years, and standards are a lot different today. When you look at the trials that preceded this trial, we learned a lot about managing hemoglobin and outcomes. When you look at the roxadustat trial, it’s everybody — and you can see disproportionately how many patients were severely anemic and had severe chronic kidney disease.”
That leads directly to the importance of the Phase III program assessing roxadustat for the treatment of patients with anemia from CKD. “Many of you are here today because we now know that the drug is effective in the cohorts of patients that we treat everyday,” Dr. Provenzano said.
The doctor led with a review of roxadustat’s efficacy. Put simply, roxadustat’s efficacy was demonstrated. Here’s how:
Roxadustat further demonstrated cardiovascular safety in all study populations.