SAN DIEGO—An investigational drug that in early clinical studies looked like it could slow progression of chronic kidney disease (CKD) has been shown in two phase 3 clinical trials that it is no better than placebo, researchers reported at Kidney Week 2012. Some subgroups of CKD patients, however, may benefit from the drug.
The two EPPIC (Evaluating Prevention of Progression In Chronic Kidney Disease) trials of AST-120 randomized 2,035 CKD patients. The primary outcome was time to initiation of dialysis, kidney transplantation, or a doubling of the baseline value for serum creatinine. Compared with placebo, AST-120 showed no benefit in patients with or without the use of ACE inhibitors or angiotensin receptor blockers. In a post-hoc analysis, however, researchers found that AST-120, an orally administered spherical carbon adsorbent, was associated with a significant 26% decreased likelihood of CKD progression among patients who were at least 80% compliant with treatment and had proteinuria or hematuria, factors associated with more rapid CKD progression.
Investigator Gerald Schulman, MD, Professor of Medicine at Vanderbilt University Medical Center in Nashville, Tenn., presented the findings of the two trials. “I hope that further studies will be forthcoming and prove that this is an effective therapy for CKD, especially in patients who have issues related to the use of RAAS [renin-angiotensin-aldosterone system] inhibition because of hyperkalemia or worsening creatinine,” he said.