- 69% of all patients studied completed treatment at 52 weeks||
FDA has not approved VELTASSA for RAAS-inhibitor maintenance.
Normokalemia was defined as serum K+ within the target range of 3.8 to 5.0 mEq/L.
A phase 2, 52-week, multicenter, open-label, dose-ranging, randomized clinical trial in patients with CKD and type 2 diabetes mellitus. Patients had serum K+ >5.0 mEq/L and were on RAAS inhibitors. In patients with a baseline serum K+ of >5.0 to 5.5 mEq/L who received an initial dose of 8.4 g/day (as a divided dose), the mean daily dose was 14 g; in those with a baseline serum K+ of >5.5 to <6.0 mEq/L who received an initial dose of 16.8 g/day (as a divided dose), the mean daily dose was 20 g during the entire study.
*Baseline serum K+=>5.0 to 5.5 mEq/L.
†Dose strength studied, but not commercially available.
‡Baseline serum K+=>5.5 to <6.0 mEq/L.
§Significant (P<0.001) increases in least squares mean serum K+ levels were seen by Day 3 post-treatment.
||Based on the 306 patients randomized to a starting dose of VELTASSA. Of the randomized patients, 304 received VELTASSA and 301 had a serum K+ value at baseline for analysis.
CKD=chronic kidney disease;
ARB=angiotensin II receptor blocker.