Table 4.
Prespecified laboratory values of interest during 4-week treatment period (safety population; n=632)
| No. of Patients (%)a | Patients with Stage 3b–5 CKD (n=421) | Patients with Stage 1–3a CKD (n=211) |
|---|---|---|
| Any serum K+ value in target range (3.8–5.0 mEq/L) | 403/418 (96) | 209/211 (99) |
| Any serum K+ value <3.5 mEq/L | 8/418 (2) | 3/211 (1) |
| Any serum value Mg2+ | ||
| <1.4 mg/dl | 19/412 (5) | 18/209 (9) |
| <1.2 mg/dl | 1/412 (0.2) | 0/209 (0.0) |
| Any serum Ca2+ value >ULNb | 21/412 (5) | 13/209 (6) |
| Any serum phosphate value >ULNc | 121/411 (29) | 24/209 (11) |
K+, potassium; Mg2+, magnesium; Ca2+, calcium; ULN, upper limit of normal.
a
Data summary is on the basis of observed patients; for some patients, laboratory values were missing during the first 4 weeks of the study.
b
Serum Ca2+ ULN >10.3 mg/dl for AMETHYST-DN, and >10.5 mg/dl for studies OPAL-HK and TOURMALINE.
c
Serum phosphate ULN >4.5 mg/dL in subjects aged <65 years, and >4.3 mg/dl in subjects aged ≥65 years for AMETHYST-DN and >4.8 mg/dL for OPAL-HK and TOURMALINE.