Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01810939 OPAL | Hyperkalemia | Change in Serum Potassium From Part A Baseline to Part A Week 4 Part A Baseline to Part A Week 4 | Part A Patiromer | -1.01 mEq/L (±0.031 Standard Error) |
| NCT01810939 OPAL | Hyperkalemia | Change in Serum Potassium From Part B Baseline Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L | Part B Patiromer | 0 mEq/L |
| Part B Placebo | 0.72 mEq/L | |||
| NCT03740048 TWOPLUS-HD | Kidney Diseases | Patients' Adherence to Study Protocol 6 months, 12 months, 24 months | Conventional Hemodialysis Regimen | 19 Participants |
| Conventional Hemodialysis Regimen | 10 Participants | |||
| Conventional Hemodialysis Regimen | 24 Participants | |||
| Hemodialysis and Pharmacologic Therapy | 19 Participants | |||
| Hemodialysis and Pharmacologic Therapy | 22 Participants | |||
| Hemodialysis and Pharmacologic Therapy | 10 Participants | |||
| NCT03888066 DIAMOND | Hyperkalemia | Changes in Serum K+ Levels From Baseline Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo | Patiromer | 0.029 Milliequivalents Per Liter (mEq/l) (±0.019 Standard Error) |
| Placebo | 0.127 Milliequivalents Per Liter (mEq/l) (±0.019 Standard Error) |