Patiromer vs Sodium zirconium cyclosilicate

NCT03888066 · Phase 3 · completed

The study randomized 878 participants to patiromer or placebo and used quadruple blinding. The primary endpoint, change in serum potassium, favored patiromer with statistical significance, but because it was a laboratory surrogate rather than a clinical or endoscopic outcome, the evidence is rated moderate.

NCT05004363 · Phase 3 · completed

The trial randomized 112 participants to Lokelma or placebo and masked participants, clinicians, investigators, and outcome assessors. Its primary outcome was achieving maximum medication doses over 16 weeks, which is a treatment-management measure rather than a hard clinical or endoscopic endpoint, and the comparison outcome has not been reported.

NCT01810939 · Phase 3 · completed

The study enrolled 243 participants and used single-blind treatment; Part A assessed patiromer without a concurrent comparator, while Part B randomized 107 patiromer responders to continued patiromer or placebo. Both primary serum-potassium comparisons favored patiromer with p<0.001, but serum potassium is a laboratory surrogate rather than a hard clinical or endoscopic endpoint.

NCT05056727 · Phase 3 · terminated

This was a large, well-designed, randomized, quadruple-blind, placebo-controlled trial using an objective kidney-function measure as its primary endpoint, but neither of its two primary comparisons (total or chronic eGFR slope) showed a statistically significant difference between sodium zirconium cyclosilicate and placebo.